Clinical Trials Update

CLASSIFIEDS

Find the job that’s right for you. PhysiciansJobsPlus allows you to post your resume, receive relevant ophthalmology open position alerts via email and apply for positions online.

Article Date: 11/1/2008

Print Friendly Page

CLINICAL TRIAL UPDATE

DRY AMD
► Study: Measuring Reading Rehabilitation Outcomes Sponsor: Dept. of Veterans Affairs Purpose: To measure the effectiveness of a newly designed oculomotor training program for patients with AMD Design: Educational, Counseling, Training, Nonrandomized, Double-blind, Active-control, Crossover Assignment, Efficacy Study Number of Patients: 90 Inclusion Criteria: Established preferred retinal locus; VA of ≤20/70 and ≥20/400 (in the better eye) Exclusion Criteria: Major ophthalmologic and neurologic disease; CNV ("wet" AMD); moderate to severe media opacities; and cognitive impairment Information: (312) 996-1466 ► Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration Sponsor: The New York Eye and Ear Infirmary Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone, which had been proven as a safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD Design: Treatment, Randomized, Double-blind (Subject, Outcomes Assessor), Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Dry AMD in 1 or both eyes; age 50 or above; either gender Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection; history of other uncontrolled systemic active disease; premenopausal females not using reliable birth control; sensitivity to fluorescein or iodine Information: ktai@nyee.edu ► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration Sponsor: Ocular Transplantation; National Neurovision Research Institute Purpose: To show that retinal transplantation can help to prevent blindness and restore eyesight in patients with dry AMD Design: Treatment, Nonrandomized, Open-label, Active-control, Factorial Assignment, Safety/Efficacy Study Number of Patients: 10 Inclusion Criteria: The subject must have decreased central VA of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye and have the diagnosis of AMD; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200; subject is older than 55 years of age; patient has undergone microperimetry and Goldmann visual field testing Exclusion Criteria: Patient having central VA of better than 20/200 in 1 eye by ETDRS or vision worse than 20/200 in 1 eye by ETDRS for a duration of less than 1 year; patient under 55 years of age; patient having medical problems that are contraindicatory for short-term anesthesia; features of any condition other than AMD in the study eye Information: nradtke@prodigy.net ► Study: Safety and Tolerability of ACU-02 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration Sponsor: Acucela Inc. Purpose: To provide an initial evaluation of the safety and tolerability of single-dose oral administration of ACU-02 in healthy volunteers in dose-escalating cohorts Design: Phase I, Randomized, Double-masked, Placebo-controlled Dose-escalating Safety Study Number of Patients: Up to 30 Inclusion Criteria: Age >55 and <80 years; healthy as determined by medical history and physical examination Information: www.acucela.com ► Study: Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration Sponsor: National Eye Institute Purpose: To investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: Participant must have at least 1/2 disc area (approximately 1 mm²) of GA compatible with AMD present in each eye. GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may still be classified as early GA Exclusion Criteria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.); history of macular laser, photodynamic therapy (PDT), intravitreal injection of any agent or any previous treatment for AMD other than high-dose vitamin supplementation Information: prpl@mail.cc.nih.gov ► Study: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-Related Macular Degeneration (AMD) Sponsor: Allergan Purpose: To evaluate the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from AMD. Patients will be followed for up to 2 years Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study Number of Patients: 95 Inclusion Criteria: Geographic atrophy in both eyes due to AMD; VA between 20/40 to 20/320 Exclusion Criteria: Known allergy to brimonidine; uncontrolled systemic disease or infection of the eye; recent eye surgery or injections in the eye Information: clinicaltrials@allergan.com

DRY AMD

► Study: Measuring Reading Rehabilitation Outcomes
Sponsor: Dept. of Veterans Affairs
Purpose: To measure the effectiveness of a newly designed oculomotor training program for patients with AMD
Design: Educational, Counseling, Training, Nonrandomized, Double-blind, Active-control, Crossover Assignment, Efficacy Study
Number of Patients: 90
Inclusion Criteria: Established preferred retinal locus; VA of ≤20/70 and ≥20/400 (in the better eye)
Exclusion Criteria: Major ophthalmologic and neurologic disease; CNV ("wet" AMD); moderate to severe media opacities; and cognitive impairment
Information: (312) 996-1466

► Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration
Sponsor: The New York Eye and Ear Infirmary
Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone, which had been proven as a safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD
Design: Treatment, Randomized, Double-blind (Subject, Outcomes Assessor), Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Dry AMD in 1 or both eyes; age 50 or above; either gender
Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection; history of other uncontrolled systemic active disease; premenopausal females not using reliable birth control; sensitivity to fluorescein or iodine
Information: ktai@nyee.edu

► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Purpose: To show that retinal transplantation can help to prevent blindness and restore eyesight in patients with dry AMD
Design: Treatment, Nonrandomized, Open-label, Active-control, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: The subject must have decreased central VA of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye and have the diagnosis of AMD; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200; subject is older than 55 years of age; patient has undergone microperimetry and Goldmann visual field testing
Exclusion Criteria: Patient having central VA of better than 20/200 in 1 eye by ETDRS or vision worse than 20/200 in 1 eye by ETDRS for a duration of less than 1 year; patient under 55 years of age; patient having medical problems that are contraindicatory for short-term anesthesia; features of any condition other than AMD in the study eye
Information: nradtke@prodigy.net

► Study: Safety and Tolerability of ACU-02 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration
Sponsor: Acucela Inc.
Purpose: To provide an initial evaluation of the safety and tolerability of single-dose oral administration of ACU-02 in healthy volunteers in dose-escalating cohorts
Design: Phase I, Randomized, Double-masked, Placebo-controlled Dose-escalating Safety Study
Number of Patients: Up to 30
Inclusion Criteria: Age >55 and <80 years; healthy as determined by medical history and physical examination
Information: www.acucela.com

► Study: Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA
Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: Participant must have at least 1/2 disc area (approximately 1 mm²) of GA compatible with AMD present in each eye. GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may still be classified as early GA
Exclusion Criteria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.); history of macular laser, photodynamic therapy (PDT), intravitreal injection of any agent or any previous treatment for AMD other than high-dose vitamin supplementation
Information: prpl@mail.cc.nih.gov

► Study: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-Related Macular Degeneration (AMD)
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from AMD. Patients will be followed for up to 2 years
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 95
Inclusion Criteria: Geographic atrophy in both eyes due to AMD; VA between 20/40 to 20/320
Exclusion Criteria: Known allergy to brimonidine; uncontrolled systemic disease or infection of the eye; recent eye surgery or injections in the eye
Information: clinicaltrials@allergan.com

WET AMD
► Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD Sponsor: OSI/Pfizer Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment Number of Patients: 1000 Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD Information: (866) 622-8436 ► Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD Sponsor: Vitreous Retina Macula Consultants of New York; Genentech Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed CNV Design: Treatment, Nonrandomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: BCVA letter score in the study eye between 73 and 24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea Contact: (212) 452-6902 ► Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD Sponsor: The National Retina Institute/Genentech Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD Number of Patients: 20 Inclusion Criteria: Age >50 years; definite characteristic signs of AMD, including drusen; presence of retinal angiomatous proliferation as determined by clinical signs and angiography Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the nonstudy eye less than 7 days preceding day 0 Contact: (301) 986-8747 ► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration Sponsor: Novartis/Greater Houston Retinal Research Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD Design: Treatment, Randomized, Open-label, Dose-comparison, Parallel Assignment, Efficacy Study Number of Patients: 30 Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and/or ICG; VA not better than 20/32 and not worse than 20/320 by ETDRS refraction Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; prior enrollment in any study for AMD Information: http://www.houstonretina.com/ ► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Sponsor: Novartis Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMD Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 318 Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to AMD Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye Information: Brandi Teske, bteske@westcoastretina.com ► Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD Sponsor: Quark Biotech, Inc. Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 42 Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200 Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months Information: (212) 452-6902 ► Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD Sponsor: Barnes Retina Institute Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne Design: Treatment, Randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study Inclusion Criteria: Treatment-naïve patients with active, subfoveal, exudative AMD; VA of 20/40 to 20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other than CNV must <50% of the total lesion size Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment Information: bristudies@barnesretinainstitute.com ► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration Sponsor: Potentia Pharmaceuticals, Inc. Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD. Design: Prospective, Uncontrolled, Nonrandomized, Single-masked, Single-dose Escalation Study Number of Patients: 18 Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm and presence of a choroidal neovascular lesion Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc. Information: federico@potentiapharma.com ► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD Sponsor: Oregon Health and Science University Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Efficacy Study Number of Patients: 300 Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; VA in treatment eye must be between 20/30 and 20/320 (ETDRS) Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye Information: (503) 494-3616 ► Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD Sponsor: NeoVista Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal CNV associated with wet AMD Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 450 Inclusion Criteria: Must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to AMD, with a total lesion size of <12 total disc areas (21.24 mm²), and a GLD ≥5.4 mm Exclusion Criteria: Prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic antiangiogenic or intravitreal antiangiogenic agents in study eye Information: (510) 933-7650, info@neovistainc.com ► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD Sponsor: Opko Health, Inc. Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pretreatment with 3 injections of Lucentis compared to Lucentis given every 4 weeks to people with wet AMD. Patients will be assigned at random to receive 1 of 3 treatments options for 104 weeks Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 330 Inclusion Criteria: Age ≥50 years old; predominantly classic, minimally classic or occult with no classic lesions secondary to AMD Exclusion Criteria: Any intraocular surgery of the study eye within 12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or IOP >22 mm Hg in the study eye Information: clinicaltrials@opko.com ► Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration Sponsor: University of California, Davis/Genentech Purpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe Design: Natural History, Longitudinal, Defined Population, Prospective Study Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 disc area Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon's Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months Information: (916) 734-6303 ► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1) Sponsor: Regeneron/Bayer Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD. Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment Number of Patients: 1200 Inclusion Criteria: Men and women ≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as assessed by FA in the study eye Information: vegf.trap@regeneron.com ► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD Sponsor: Jerini Ophthalmic Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 36 Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous RPE detachment without the presence of neovascularization Information: (919) 226-1440 ×325 ► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST) Sponsor: Retina Vitreous Associates, P.C.; Genentech Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab vs the standard dose (0.5 mg), in adults with AMD who have never been treated with ranibizumab. Design: Treatment, Randomized, Open-label, Parallel Assignment Number of Patients: 30 Inclusion Criteria: Treatment naive macular degeneration patients with CNV; >50 years old; VA 20/40 to 20/320 Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke Information: cawh@aol.com ► Study: Sensitivity of the Home Macular Perimeter (HMP) Sponsor: Notal Vision Ltd Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD Design: Cohort, Prospective Number of Patients: 20 Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) nontreated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA Information: osnat@notalvision.com ► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD Sponsor: GlaxoSmithKline Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients Design: Treatment, Randomized, Double-blind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study Number of Patients: 60 Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal CNV in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa) Information: (877) 379-3718 ► Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corp. Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD Design: Treatment, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: Subfoveal CNV due to AMD Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function Information: denise.teuber@ophthotech.com ► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial Sponsor: National Eye Institute Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule Design: Treatment, Randomized, Double-blind (Caregiver, Investigator, Outcomes Assessor), Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 1200 Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV); subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25 to 20/320; age ≥50 yrs; at least 1 druse (>63 μm) in either eye or late AMD in fellow eye Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin Information: dan.martin@emory.edu ► Study: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF Sponsor: CoMentis Purpose: To study the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria: >55 years of age; clinical diagnosis of neovascular AMD Exclusion Criteria: Confounding ocular condition Information: jmonk@comentis.com ► Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration Sponsor: National Eye Institute Purpose: To examine whether the antiinflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Age ≥55 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; any antiangiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy Exclusion Criteria: CNV in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc. Information: (800) 411-1222 ► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration Sponsor: Allergan Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-VEGF treatment vs anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to AMD Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Outcomes Assessor), Active-control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 200 Inclusion Criteria: >50 years old with subfoveal CNV secondary to AMD; VA between 20/40 and 20/400 in the study eye Exclusion Criteria: Any intraocular surgery within 3 months; glaucoma or cataract; high IOP; uncontrolled systemic disease Information: clinicaltrials@allergan.com ► Study: The MAP Study: FA/Medidur for AMD Pilot Sponsor: Johns Hopkins University/Alimera Sciences Purpose: To compare the safety of 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau Design: Treatment, Randomized, Singleblind (Subject), Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Patients treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4 to 6 weeks apart) with no improvement in VA (worse or within 1 line better) or center subfield thickening Exclusion Criteria: Pregnant, lactating females or females of childbearing potential; glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye Information: ghafiz1@jhmi.edu ► Study: Antioxidant Systems and Age-Related Macular Degeneration Sponsor: Vanderbilt University/National Institutes of Health Purpose: To determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state Design: Case-only, Prospective Number of Patients: 140 Inclusion Criteria: Intermediate or advanced AMD; any race and either sex Exclusion Criteria: History of a medical condition that would preclude scheduled study visits or completion of the study; history of an ophthalmic disease in the study eye that would likely compromise the VA of the study eye Information: paul.sternberg@vanderbilt.edu ► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration Sponsor: National Eye Institute Purpose: To use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet AMD Design: Prospective Number of Patients: 50 Inclusion Criteria: Must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD Exclusion Criteria: CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; geographic atrophy or fibrosis under the fovea Information: prpl@mail.cc.nih.gov ► Study: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA) Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech Purpose: To study a combination therapy using efalizumab and ranibizumab that could target the adhesion factors that precede angiogenesis and improve the outcome for AMD patients in combination with the anti-VEGF agent, ranibizumab Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment Number of Patients: 10 Inclusion Criteria: Demonstrate ability to perform weekly self subcutaneous injections; BCVA in the study eye between 20/40 and 20/320 Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception; prior treatment with PDT Information: (212) 452-6965 ► Study: ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corporation Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 70 Inclusion Criteria: Subfoveal CNV due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram Exclusion Criteria: Previous or concomitant therapy with intravitreous corticosteroids Information: dbeutelspacher@ophthotech.com ► Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration Sponsor: Oklahoma State University Center for Health Sciences/Novartis Purpose: To compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative AMD Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin Information: (918) 747-7799 ► Study: Pilot Study Reduced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD) Sponsor: Lahey Clinic Purpose: To determine if combination reduced fluence PDT and Ranibizumab has similar efficacy to Ranibizumab alone Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment Number of Patients: 20 Inclusion Criteria: FA diagnosis of CNV lesions as described above Exclusion Criteria: Dense subfoveal hemorrhage; tear or rip of the RPE, idiopathic parafoveal telangiectasis or serous RPE without CNV Information: Avon.P.Stewart@Lahey.org ► Study: SEAGUL: Study Evaluating Genotypes Using Lucentis Sponsor: University of Utah/Genentech Purpose: To investigate whether the efficacy of Lucentis treatment for exudative AMD is associated with VEGF and HTRA1 DNA polymorphisms Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study Inclusion Criteria: Treatment naive AMD patients; at least 50 years of age Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial Information: jeanette.buehler@hsc.utah.edu ► Study: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Sponsor: MacuSight, Inc. Purpose: To determine the safety and efficacy of an ocular sirolimus formulation via different injection routes in patients with treatment-naive subfoveal CNV secondary to AMD Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Diagnosed with subfoveal CNV secondary to AMD Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye Information: ebaj@retinalconsultantsaz.com

WET AMD

► Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Sponsor: OSI/Pfizer
Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment
Number of Patients: 1000
Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD
Information: (866) 622-8436

► Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD
Sponsor: Vitreous Retina Macula Consultants of New York; Genentech
Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed CNV
Design: Treatment, Nonrandomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: BCVA letter score in the study eye between 73 and 24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye
Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea
Contact: (212) 452-6902

► Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD
Sponsor: The National Retina Institute/Genentech
Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD
Number of Patients: 20
Inclusion Criteria: Age >50 years; definite characteristic signs of AMD, including drusen; presence of retinal angiomatous proliferation as determined by clinical signs and angiography
Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the nonstudy eye less than 7 days preceding day 0
Contact: (301) 986-8747

► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor: Novartis/Greater Houston Retinal Research
Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD
Design: Treatment, Randomized, Open-label, Dose-comparison, Parallel Assignment, Efficacy Study
Number of Patients: 30
Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and/or ICG; VA not better than 20/32 and not worse than 20/320 by ETDRS refraction
Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; prior enrollment in any study for AMD
Information: http://www.houstonretina.com/

► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Sponsor: Novartis
Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMD
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 318
Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to AMD
Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye
Information: Brandi Teske, bteske@westcoastretina.com

► Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
Sponsor: Quark Biotech, Inc.
Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 42
Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200
Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months
Information: (212) 452-6902

► Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor: Barnes Retina Institute
Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne
Design: Treatment, Randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study
Inclusion Criteria: Treatment-naïve patients with active, subfoveal, exudative AMD; VA of 20/40 to 20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other than CNV must <50% of the total lesion size
Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment
Information: bristudies@barnesretinainstitute.com

► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Potentia Pharmaceuticals, Inc.
Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD.
Design: Prospective, Uncontrolled, Nonrandomized, Single-masked, Single-dose Escalation Study
Number of Patients: 18
Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm and presence of a choroidal neovascular lesion
Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
Information: federico@potentiapharma.com

► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Sponsor: Oregon Health and Science University
Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Efficacy Study
Number of Patients: 300
Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; VA in treatment eye must be between 20/30 and 20/320 (ETDRS)
Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye
Information: (503) 494-3616

► Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD
Sponsor: NeoVista
Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal CNV associated with wet AMD
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 450
Inclusion Criteria: Must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to AMD, with a total lesion size of <12 total disc areas (21.24 mm²), and a GLD ≥5.4 mm
Exclusion Criteria: Prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic antiangiogenic or intravitreal antiangiogenic agents in study eye
Information: (510) 933-7650, info@neovistainc.com

► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Sponsor: Opko Health, Inc.
Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pretreatment with 3 injections of Lucentis compared to Lucentis given every 4 weeks to people with wet AMD. Patients will be assigned at random to receive 1 of 3 treatments options for 104 weeks
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 330
Inclusion Criteria: Age ≥50 years old; predominantly classic, minimally classic or occult with no classic lesions secondary to AMD
Exclusion Criteria: Any intraocular surgery of the study eye within 12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or IOP >22 mm Hg in the study eye
Information: clinicaltrials@opko.com

► Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration
Sponsor: University of California, Davis/Genentech
Purpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 disc area
Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon's Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months
Information: (916) 734-6303

► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)
Sponsor: Regeneron/Bayer
Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD.
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment
Number of Patients: 1200
Inclusion Criteria: Men and women ≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as assessed by FA in the study eye
Information: vegf.trap@regeneron.com

► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
Sponsor: Jerini Ophthalmic
Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 36
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD
Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous RPE detachment without the presence of neovascularization
Information: (919) 226-1440 ×325

► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab vs the standard dose (0.5 mg), in adults with AMD who have never been treated with ranibizumab.
Design: Treatment, Randomized, Open-label, Parallel Assignment
Number of Patients: 30
Inclusion Criteria: Treatment naive macular degeneration patients with CNV; >50 years old; VA 20/40 to 20/320
Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke
Information: cawh@aol.com

► Study: Sensitivity of the Home Macular Perimeter (HMP)
Sponsor: Notal Vision Ltd
Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Design: Cohort, Prospective
Number of Patients: 20
Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) nontreated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage
Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA
Information: osnat@notalvision.com

► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Sponsor: GlaxoSmithKline
Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Design: Treatment, Randomized, Double-blind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Number of Patients: 60
Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal CNV in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT
Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa)
Information: (877) 379-3718

► Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Subfoveal CNV due to AMD
Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function
Information: denise.teuber@ophthotech.com

► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Sponsor: National Eye Institute
Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule
Design: Treatment, Randomized, Double-blind (Caregiver, Investigator, Outcomes Assessor), Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 1200
Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV); subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25 to 20/320; age ≥50 yrs; at least 1 druse (>63 μm) in either eye or late AMD in fellow eye
Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin
Information: dan.martin@emory.edu

► Study: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Sponsor: CoMentis
Purpose: To study the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: >55 years of age; clinical diagnosis of neovascular AMD
Exclusion Criteria: Confounding ocular condition
Information: jmonk@comentis.com

► Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To examine whether the antiinflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD
Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Age ≥55 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; any antiangiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy
Exclusion Criteria: CNV in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
Information: (800) 411-1222

► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-VEGF treatment vs anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Outcomes Assessor), Active-control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 200
Inclusion Criteria: >50 years old with subfoveal CNV secondary to AMD; VA between 20/40 and 20/400 in the study eye
Exclusion Criteria: Any intraocular surgery within 3 months; glaucoma or cataract; high IOP; uncontrolled systemic disease
Information: clinicaltrials@allergan.com

► Study: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins University/Alimera Sciences
Purpose: To compare the safety of 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau
Design: Treatment, Randomized, Singleblind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Patients treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4 to 6 weeks apart) with no improvement in VA (worse or within 1 line better) or center subfield thickening
Exclusion Criteria: Pregnant, lactating females or females of childbearing potential; glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye
Information: ghafiz1@jhmi.edu

► Study: Antioxidant Systems and Age-Related Macular Degeneration
Sponsor: Vanderbilt University/National Institutes of Health
Purpose: To determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state
Design: Case-only, Prospective
Number of Patients: 140
Inclusion Criteria: Intermediate or advanced AMD; any race and either sex
Exclusion Criteria: History of a medical condition that would preclude scheduled study visits or completion of the study; history of an ophthalmic disease in the study eye that would likely compromise the VA of the study eye
Information: paul.sternberg@vanderbilt.edu

► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet AMD
Design: Prospective
Number of Patients: 50
Inclusion Criteria: Must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD
Exclusion Criteria: CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; geographic atrophy or fibrosis under the fovea
Information: prpl@mail.cc.nih.gov

► Study: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA)
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Purpose: To study a combination therapy using efalizumab and ranibizumab that could target the adhesion factors that precede angiogenesis and improve the outcome for AMD patients in combination with the anti-VEGF agent, ranibizumab
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Number of Patients: 10
Inclusion Criteria: Demonstrate ability to perform weekly self subcutaneous injections; BCVA in the study eye between 20/40 and 20/320
Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception; prior treatment with PDT
Information: (212) 452-6965

► Study: ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 70
Inclusion Criteria: Subfoveal CNV due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram
Exclusion Criteria: Previous or concomitant therapy with intravitreous corticosteroids
Information: dbeutelspacher@ophthotech.com

► Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Sponsor: Oklahoma State University Center for Health Sciences/Novartis
Purpose: To compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative AMD
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT
Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin
Information: (918) 747-7799

► Study: Pilot Study Reduced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD)
Sponsor: Lahey Clinic
Purpose: To determine if combination reduced fluence PDT and Ranibizumab has similar efficacy to Ranibizumab alone
Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment
Number of Patients: 20
Inclusion Criteria: FA diagnosis of CNV lesions as described above
Exclusion Criteria: Dense subfoveal hemorrhage; tear or rip of the RPE, idiopathic parafoveal telangiectasis or serous RPE without CNV
Information: Avon.P.Stewart@Lahey.org

► Study: SEAGUL: Study Evaluating Genotypes Using Lucentis
Sponsor: University of Utah/Genentech
Purpose: To investigate whether the efficacy of Lucentis treatment for exudative AMD is associated with VEGF and HTRA1 DNA polymorphisms
Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Inclusion Criteria: Treatment naive AMD patients; at least 50 years of age
Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial
Information: jeanette.buehler@hsc.utah.edu

► Study: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
Sponsor: MacuSight, Inc.
Purpose: To determine the safety and efficacy of an ocular sirolimus formulation via different injection routes in patients with treatment-naive subfoveal CNV secondary to AMD
Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Diagnosed with subfoveal CNV secondary to AMD
Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye
Information: ebaj@retinalconsultantsaz.com

SCREENING
► Study: Evaluation and Treatment of Patients with Retinal Disease Sponsor: National Eye Institute Status: Enrolling patients Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area Design: Natural history Number of Patients: 500 Inclusion Criteria: Diagnosis of AMD Exclusion Criteria: Inability to be followed for 3 years Contact: (800) 411-1222 ► Study: Screening for Studies on Retinovascular Diseases Sponsor: National Eye Institute Status: Enrolling patients Purpose: To help recruit patients for NEI studies of the retina Design: Natural History Number of Patients: 1500 Inclusion and Exclusion Criteria: Criteria vary with the particular protocol for which a patient is being screened Contact: (800) 411-1222 ► Study: Genetic Factors in AMD Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine whether certain poly morphisms predispose people to develop AMD Design: Screening Number of Patients: 400 Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss Information: (800) 411-1222 ► Study: Investigating Age-Related Macular Degeneration Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine an Amish community to investigate genetic factors in the development of AMD Design: Natural History Number of Patients: 1000 Inclusion Criteria: All Amish individuals, ≥50 years Information: (301) 496-6583 ► Study: Ultrasonic Evaluation of Ocular Tissues Sponsor: Weill Medical College of Cornell University/Riverside Research Institute Status: Currently enrolling Purpose: To improve diagnosis and treat ment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques Design: Screening, Cross-sectional, Defined-population, Retrospective/Prospective Study Number of Patients: 150 Inclusion Criteria: Have 1 of the following eye diseases: glaucoma, ocular tumors, AMD Information: (212) 746-6106

SCREENING

► Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area
Design: Natural history
Number of Patients: 500
Inclusion Criteria: Diagnosis of AMD
Exclusion Criteria: Inability to be followed for 3 years
Contact: (800) 411-1222

► Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To help recruit patients for NEI studies of the retina
Design: Natural History
Number of Patients: 1500
Inclusion and Exclusion Criteria: Criteria vary with the particular protocol for which a patient is being screened
Contact: (800) 411-1222

► Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain poly morphisms predispose people to develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD
Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss
Information: (800) 411-1222

► Study: Investigating Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine an Amish community to investigate genetic factors in the development of AMD
Design: Natural History
Number of Patients: 1000
Inclusion Criteria: All Amish individuals, ≥50 years
Information: (301) 496-6583

► Study: Ultrasonic Evaluation of Ocular Tissues
Sponsor: Weill Medical College of Cornell University/Riverside Research Institute
Status: Currently enrolling
Purpose: To improve diagnosis and treat ment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques
Design: Screening, Cross-sectional, Defined-population, Retrospective/Prospective Study
Number of Patients: 150
Inclusion Criteria: Have 1 of the following eye diseases: glaucoma, ocular tumors, AMD
Information: (212) 746-6106

DIABETIC MACULAR EDEMA
► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema Sponsor: Allergan Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME Design: Treatment, Randomized, Double-blind, Dose-comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 860 Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse), other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin Information: clinicaltrials@allergan.com ► Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME) Sponsor: NEI/Genentech/Allergan Purpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 701 Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2) Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry Information: (866) 372-7601 ×218 ► Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema Sponsor: Eli Lilly and Company Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by OCT, in patients with clinically significant macular edema Design: Treatment, Randomized, Double-blind, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 220 Inclusion Criteria: Type 1 or 2 diabetes; ≥18 years old; HbA1c less than or equal to 11%; mild to very severe nonproliferative diabetic retinopathy in the study eye; clinically significant macular edema in the study eye Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye; glaucoma in the study eye; unstable cardiovascular disease Information: (877) 285-4559 ► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy Sponsor: NEI/Genentech/Allergan Purpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 380 Inclusion Criteria: Type 1 or 2 diabetics age ≥18 years Exclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization Information: (866) 372-7601 ► Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus Sponsor: Genentech Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2) Design: Treatment Number of Patients: 366 Inclusion Criteria: Retinal thickening secondary to diabetes mellitus involving the center of the fovea with central macular thickness >275 μm in the center subfield Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry Information: lane.hayley@gene.com ► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema Sponsor: Allergan Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 250 Inclusion Criteria: Decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse) and VA in other eye no worse than 20/200 Exclusion Criteria: History of glaucoma or current high IOP requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin Information: clinicaltrials@allergan.com ► Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME Sponsor: ThromboGenics Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME Design: Treatment, Randomized, Double-blind, Dose-comparison, Single Group Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria: >18 years old with DME Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time Information: (212) 201-0920 × ► Study: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RIDE) Sponsor: Genentech Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (type 1 or 2) Design: Treatment Number of Patients: 366 Inclusion Criteria: Age ≥18 years; diabetes mellitus (Type 1 or 2); retinal thickening secondary to diabetes mellitus (DME); BCVA score in the study eye of 20/40 to 20/320; decrease in vision determined to be primarily the result of DME and not to other causes Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening; previous use of intraocular corticosteroids in the study eye within 3 months of screening Information: (888) 662-6728 ► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema Sponsor: Rocky Mountain Retina Consultants/Genentech Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of diabetic macular edema as compared to grid/focal laser Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 60 Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991) Exclusion Criteria: Intraocular pressures exceed 25 mm Hg; participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin Information: study@rmrc.xohost.com ► Study: Combined Approach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation/Genentech Purpose: To continue the study of anti-VEGF therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined anti-VEGF and anti-inflammatory Design: Treatment, Randomized, Open-label, Dose-comparison, Factorial Assignment, Safety/Efficacy Study Number of Patients: 72 Inclusion Criteria: 18 years of age; diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c 5.5% within 12 months of randomization; retinal thickening (DME) involving the center of the fovea Exclusion Criteria: Panretinal or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry Information: jdenton2@jhmi.edu ► Study: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy Sponsor: Novagali Pharma Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: Age ≥18 years old; diagnosed with diabetes mellitus and presenting diabetic retinopathy Exclusion Criteria: Monocularity; history of current ocular hypertension or glaucoma in either eye defined; any significant ocular disease (other than diabetic retinopathy) Information: mourad.amrane@novagali.com ► Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II) Sponsor: Genentech/Michael J. Jumper Purpose: To study the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5 mg in subjects with proliferative diabetic retinopathy experiencing post-panretinal photocoagulation (PRP) macular edema Design: Treatment, Randomized, Open-label, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and OCT AND 7-14 day post-PRP OCT; previously untreated PDR patients with high-risk characteristics who develop edema within 7 to 14 days post-PRP therapy Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant DME that would make the patient eligible for macular laser prior to PRP Information: jrose@westcoastretina.com ► Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema Sponsor: MacuSight, Inc. Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with DME Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo-control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 120 Inclusion Criteria: Diagnosis of diabetes mellitus; macular edema secondary to diabetic retinopathy; VA of 20/40 to 20/200 in study eye Exclusion Criteria: Any other ocular disease in the study eye; any intravitreal injections, posterior subtenons steroids, photocoagulation, or intraocular surgery in study eye within 90 days Information: cdelpouys@macusight.com ► Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR) Sponsor: Retina Research Foundation Purpose: To determine if infliximab injections into the eye are safe Design: Treatment, Nonrandomized, Open Label, Single Group Assignment, Safety Study Number of Patients: 4 Inclusion Criteria: Age >21 years; patients with active CNV secondary to AMD in the study eye that did not improve with conventional therapy; patients with refractory DME in the study eye that did not improve with conventional therapy Exclusion Criteria: Inability to obtain photographs, FA, or OCT to document CNV Information: (518) 533-6550 ► Study: Sirolimus to Treat Diabetic Macular Edema Sponsor: National Eye Institute Purpose: To test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with diabetic macular edema Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study Number of Patients: 8 Inclusion Criteria: Documented hemoglobin A1C 12% or less within one month of baseline Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; condition that, in the opinion of the investigator, would preclude participation in the study Information: (800) 411-1222 ► Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema Sponsor: Pfizer Purpose: To evaluate the effectiveness of study drug in improving VA compared to laser treatment in the patients with DME Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study Number of Patients: 160 Inclusion Criteria: Patients with diabetes mellitus showing DME Exclusion Criteria: PDR in the study eye; receiving concomitant intravitreal anti-VEGF therapy Information: (800) 718-1021 ► Study: Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema Sponsor: Bp Consulting, Inc. Purpose: To determine if bromfenac reduces DME as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study Number of Patients: 50 Inclusion Criteria: Male or female >18 years of age scheduled to undergo argon laser therapy. Patients with DME and/or PDR as evidenced by ophthalmic examination and diagnostics, with either central macular or peripheral involvement Exclusion Criteria: Patients who received intra-vitreal/sub-tenon corticosteroid injections; macular scarring/fibrosis, advanced cataract, advanced glaucoma, retinal pigment epithelial detachments (RPEDs); other causes affecting visual improvement; allergy to bromfenac or NSAIDS; sensitivity to sulfite Information: michelle-bpconsulting@yahoo.com

DIABETIC MACULAR EDEMA

► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME
Design: Treatment, Randomized, Double-blind, Dose-comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 860
Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse), other eye no worse than 20/200
Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin
Information: clinicaltrials@allergan.com

► Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME)
Sponsor: NEI/Genentech/Allergan
Purpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 701
Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2)
Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry
Information: (866) 372-7601 ×218

► Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by OCT, in patients with clinically significant macular edema
Design: Treatment, Randomized, Double-blind, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 220
Inclusion Criteria: Type 1 or 2 diabetes; ≥18 years old; HbA1c less than or equal to 11%; mild to very severe nonproliferative diabetic retinopathy in the study eye; clinically significant macular edema in the study eye
Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye; glaucoma in the study eye; unstable cardiovascular disease
Information: (877) 285-4559

► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor: NEI/Genentech/Allergan
Purpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 380
Inclusion Criteria: Type 1 or 2 diabetics age ≥18 years
Exclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization
Information: (866) 372-7601

► Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Sponsor: Genentech
Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Retinal thickening secondary to diabetes mellitus involving the center of the fovea with central macular thickness >275 μm in the center subfield
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry
Information: lane.hayley@gene.com

► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 250
Inclusion Criteria: Decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse) and VA in other eye no worse than 20/200
Exclusion Criteria: History of glaucoma or current high IOP requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin
Information: clinicaltrials@allergan.com

► Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME
Sponsor: ThromboGenics
Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME
Design: Treatment, Randomized, Double-blind, Dose-comparison, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: >18 years old with DME
Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time
Information: (212) 201-0920 ×

► Study: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RIDE)
Sponsor: Genentech
Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Age ≥18 years; diabetes mellitus (Type 1 or 2); retinal thickening secondary to diabetes mellitus (DME); BCVA score in the study eye of 20/40 to 20/320; decrease in vision determined to be primarily the result of DME and not to other causes
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening; previous use of intraocular corticosteroids in the study eye within 3 months of screening
Information: (888) 662-6728

► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor: Rocky Mountain Retina Consultants/Genentech
Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of diabetic macular edema as compared to grid/focal laser
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 60
Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991)
Exclusion Criteria: Intraocular pressures exceed 25 mm Hg; participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin
Information: study@rmrc.xohost.com

► Study: Combined Approach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation/Genentech
Purpose: To continue the study of anti-VEGF therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined anti-VEGF and anti-inflammatory
Design: Treatment, Randomized, Open-label, Dose-comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 72
Inclusion Criteria: 18 years of age; diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c 5.5% within 12 months of randomization; retinal thickening (DME) involving the center of the fovea
Exclusion Criteria: Panretinal or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry
Information: jdenton2@jhmi.edu

► Study: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Sponsor: Novagali Pharma
Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Age ≥18 years old; diagnosed with diabetes mellitus and presenting diabetic retinopathy
Exclusion Criteria: Monocularity; history of current ocular hypertension or glaucoma in either eye defined; any significant ocular disease (other than diabetic retinopathy)
Information: mourad.amrane@novagali.com

► Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Sponsor: Genentech/Michael J. Jumper
Purpose: To study the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5 mg in subjects with proliferative diabetic retinopathy experiencing post-panretinal photocoagulation (PRP) macular edema
Design: Treatment, Randomized, Open-label, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and OCT AND 7-14 day post-PRP OCT; previously untreated PDR patients with high-risk characteristics who develop edema within 7 to 14 days post-PRP therapy
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant DME that would make the patient eligible for macular laser prior to PRP
Information: jrose@westcoastretina.com

► Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
Sponsor: MacuSight, Inc.
Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with DME
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo-control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 120
Inclusion Criteria: Diagnosis of diabetes mellitus; macular edema secondary to diabetic retinopathy; VA of 20/40 to 20/200 in study eye
Exclusion Criteria: Any other ocular disease in the study eye; any intravitreal injections, posterior subtenons steroids, photocoagulation, or intraocular surgery in study eye within 90 days
Information: cdelpouys@macusight.com

► Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)
Sponsor: Retina Research Foundation
Purpose: To determine if infliximab injections into the eye are safe
Design: Treatment, Nonrandomized, Open Label, Single Group Assignment, Safety Study
Number of Patients: 4
Inclusion Criteria: Age >21 years; patients with active CNV secondary to AMD in the study eye that did not improve with conventional therapy; patients with refractory DME in the study eye that did not improve with conventional therapy
Exclusion Criteria: Inability to obtain photographs, FA, or OCT to document CNV
Information: (518) 533-6550

► Study: Sirolimus to Treat Diabetic Macular Edema
Sponsor: National Eye Institute
Purpose: To test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with diabetic macular edema
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Number of Patients: 8
Inclusion Criteria: Documented hemoglobin A1C 12% or less within one month of baseline
Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; condition that, in the opinion of the investigator, would preclude participation in the study
Information: (800) 411-1222

► Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
Sponsor: Pfizer
Purpose: To evaluate the effectiveness of study drug in improving VA compared to laser treatment in the patients with DME
Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 160
Inclusion Criteria: Patients with diabetes mellitus showing DME
Exclusion Criteria: PDR in the study eye; receiving concomitant intravitreal anti-VEGF therapy
Information: (800) 718-1021

► Study: Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema
Sponsor: Bp Consulting, Inc.
Purpose: To determine if bromfenac reduces DME as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States
Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Number of Patients: 50
Inclusion Criteria: Male or female >18 years of age scheduled to undergo argon laser therapy. Patients with DME and/or PDR as evidenced by ophthalmic examination and diagnostics, with either central macular or peripheral involvement
Exclusion Criteria: Patients who received intra-vitreal/sub-tenon corticosteroid injections; macular scarring/fibrosis, advanced cataract, advanced glaucoma, retinal pigment epithelial detachments (RPEDs); other causes affecting visual improvement; allergy to bromfenac or NSAIDS; sensitivity to sulfite
Information: michelle-bpconsulting@yahoo.com

UVEITIS
► Study: MUST: Multicenter Uveitis Steroid Treatment Sponsor: National Eye Institute Purpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of noninfectious intermediate uveitis, posterior uveitis, or panuveitis Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 400 Inclusion Criteria: Age ≥18; BCVA of 20/200 in at least 1 eye with severe uveitis; IOP 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitis Exclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 antiglaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar Information: (301) 451-2020 ► Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases Sponsor: National Eye Institute Purpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments Design: Natural History Number of Patients: 200 Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory disease Information: (800) 411-1222 ► Study: Study of Difluprednate in the Treatment of Uveitis Sponsor: Sirion Therapeutics Purpose: To determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis Design: Multicenter, Randomized, Double-masked, Parallel-group, Active-controlled Number of Patients: 90 Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterior uveitis in at least 1 eye Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected activekeratoconjunctival disease Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com ► Study: Immune Indicators of Uveitis Sponsor: National Eye Institute Purpose: To identify markers of immune UVEITIS activity in uveitis patients that correlate with the state of disease activity. Design: Observational Number of Patients: 100 Inclusion Criteria: Patients with bilateral sight-threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Exclusion Criteria: Pregnancy; having another disease or condition affecting vision that will interfere with obtaining study data Information: prpl@mail.cc.nih.gov ► Study: Quality of Life and Visual Function in Uveitis Patients Sponsor: New York Eye and Ear Infirmar Purpose: To measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis Design: Screening, Cross-sectional, Defined-population, Prospective Study Number of Patients: 50 Inclusion Criteria: Age >18 years old; diagnosis of uveitis Information: (212) 979-4251 ► Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis Sponsor: Novartis Purpose: To assess the efficacy of AEB071 300 mg twice daily as a therapy for uveitis, using reduction in swelling of the retina as a primary endpoint Design: Treatment, Randomized, Double-blind (Subject, Investigator), Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 40 Inclusion Criteria: Male and female patients with noninfectious intermediate or posterior uveitis or panuveitis in at least 1 eye Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness Information: (862) 778-8300 ► Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease Sponsor: National Eye Institute Purpose: To examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis Design: Observational Number of Patients: 5 Inclusion Criteria: Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant Exclusion Criteria: Patients who have met the criteria for participation in the MUST study and do not wish to donate their vitreous specimen or blood sample Information: prpl@mail.cc.nih.gov ► Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases Sponsor: National Eye Institute Purpose: To study epigenetic mechanisms, the inheritance of (both Mendelian and complex) and biomarkers of immune-mediated eye diseases, in families of many nationalities and ethnic backgrounds in order to identify the genes that, when mutated or demethylated or aceytylated, cause immune mediated eye disease, and the pathophysiology through which they act Design: Observational Number of Patients: 500 Inclusion Criteria: Individuals or family members of individuals with immunemediated retinal disorders Exclusion Criteria: Individuals with diseases, infections, or trauma that mimic immune medicated retinal disorders Information: prpl@mail.cc.nih.gov ► Study: LIME: Lucentis for Inflammatory Macular Edema Trial Sponsor: University of California, San Francisco/Genentech Purpose: To determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or are nonresponsive to steroids Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Number of Patients: 10 Inclusion Criteria: History of noninfectious uveitis with chronic CME (>3 months duration); anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study Information: kevin.hong@ucsf.edu ► Study: Safety, Tolerability, and Efficacy of AIN457 in the Treatment of Uveitis Sponsor: Novartis Purpose: To assess the safety, tolerability, and efficacy of intravenous AIN457 as a therapy for uveitis. To assess the ability of intravenous AIN457 to reduce intraocular inflammation, and to reduce oral prednisone or topical corticosteroid use in uveitis patients Design: Treatment, Open-label, Historical Control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: Male and female subjects age 18 to 75 (inclusive) years of age; patients with noninfectious uveitis requiring systemic immunosuppression with agents other than or in addition to prednisone Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy Information: (862) 778-8300 ► Study: Corticosteroid Implant vs. Oral Corticosteroid Treatment for Uveitis Sponsor: National Eye Institute Purpose: To test whether a new corticosteroid implant is more effective for reducing eye inflammation in patients with uveitis than the standard treatment with oral corticosteroids Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 250 Inclusion Criteria: Diagnosis of active, recurrent, chronic non-infectious intermediate, posterior, or panuveitis Exclusion Criteria: Diabetes mellitus that is inadequately controlled, according to best medical judgment; known allergy to a required study medication; yncontrolled glaucoma Information: prpl@mail.cc.nih.gov

UVEITIS

► Study: MUST: Multicenter Uveitis Steroid Treatment
Sponsor: National Eye Institute
Purpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of noninfectious intermediate uveitis, posterior uveitis, or panuveitis
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 400
Inclusion Criteria: Age ≥18; BCVA of 20/200 in at least 1 eye with severe uveitis; IOP 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitis
Exclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 antiglaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar
Information: (301) 451-2020

► Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases
Sponsor: National Eye Institute
Purpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments
Design: Natural History
Number of Patients: 200
Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory disease
Information: (800) 411-1222

► Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Purpose: To determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis
Design: Multicenter, Randomized, Double-masked, Parallel-group, Active-controlled
Number of Patients: 90
Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterior uveitis in at least 1 eye
Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected activekeratoconjunctival disease
Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

► Study: Immune Indicators of Uveitis
Sponsor: National Eye Institute
Purpose: To identify markers of immune UVEITIS activity in uveitis patients that correlate with the state of disease activity.
Design: Observational
Number of Patients: 100
Inclusion Criteria: Patients with bilateral sight-threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible.
Exclusion Criteria: Pregnancy; having another disease or condition affecting vision that will interfere with obtaining study data
Information: prpl@mail.cc.nih.gov

► Study: Quality of Life and Visual Function in Uveitis Patients
Sponsor: New York Eye and Ear Infirmar
Purpose: To measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis
Design: Screening, Cross-sectional, Defined-population, Prospective Study
Number of Patients: 50
Inclusion Criteria: Age >18 years old; diagnosis of uveitis
Information: (212) 979-4251

► Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Sponsor: Novartis
Purpose: To assess the efficacy of AEB071 300 mg twice daily as a therapy for uveitis, using reduction in swelling of the retina as a primary endpoint
Design: Treatment, Randomized, Double-blind (Subject, Investigator), Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 40
Inclusion Criteria: Male and female patients with noninfectious intermediate or posterior uveitis or panuveitis in at least 1 eye
Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness
Information: (862) 778-8300

► Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Purpose: To examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis
Design: Observational
Number of Patients: 5
Inclusion Criteria: Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant
Exclusion Criteria: Patients who have met the criteria for participation in the MUST study and do not wish to donate their vitreous specimen or blood sample
Information: prpl@mail.cc.nih.gov

► Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases
Sponsor: National Eye Institute
Purpose: To study epigenetic mechanisms, the inheritance of (both Mendelian and complex) and biomarkers of immune-mediated eye diseases, in families of many nationalities and ethnic backgrounds in order to identify the genes that, when mutated or demethylated or aceytylated, cause immune mediated eye disease, and the pathophysiology through which they act
Design: Observational
Number of Patients: 500
Inclusion Criteria: Individuals or family members of individuals with immunemediated retinal disorders
Exclusion Criteria: Individuals with diseases, infections, or trauma that mimic immune medicated retinal disorders
Information: prpl@mail.cc.nih.gov

► Study: LIME: Lucentis for Inflammatory Macular Edema Trial
Sponsor: University of California, San Francisco/Genentech
Purpose: To determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or are nonresponsive to steroids
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: History of noninfectious uveitis with chronic CME (>3 months duration); anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation
Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study
Information: kevin.hong@ucsf.edu

► Study: Safety, Tolerability, and Efficacy of AIN457 in the Treatment of Uveitis
Sponsor: Novartis
Purpose: To assess the safety, tolerability, and efficacy of intravenous AIN457 as a therapy for uveitis. To assess the ability of intravenous AIN457 to reduce intraocular inflammation, and to reduce oral prednisone or topical corticosteroid use in uveitis patients
Design: Treatment, Open-label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: Male and female subjects age 18 to 75 (inclusive) years of age; patients with noninfectious uveitis requiring systemic immunosuppression with agents other than or in addition to prednisone
Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy
Information: (862) 778-8300

► Study: Corticosteroid Implant vs. Oral Corticosteroid Treatment for Uveitis
Sponsor: National Eye Institute
Purpose: To test whether a new corticosteroid implant is more effective for reducing eye inflammation in patients with uveitis than the standard treatment with oral corticosteroids
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 250
Inclusion Criteria: Diagnosis of active, recurrent, chronic non-infectious intermediate, posterior, or panuveitis
Exclusion Criteria: Diabetes mellitus that is inadequately controlled, according to best medical judgment; known allergy to a required study medication; yncontrolled glaucoma
Information: prpl@mail.cc.nih.gov

COMPLETED ENROLLMENT
► Study: Age-Related Eye Disease Study II (AREDS II) Sponsor: National Eye Institute Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 ► Study: Evaluation and Treatment of Patients with Retinal Disease Sponsor: National Eye Institute Contact: (800) 411-1222 ► Study: Screening for Studies on Retinovascular Diseases Sponsor: National Eye Institute Contact: (800) 411-1222 ► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy Sponsor: Diabetic Retinopathy Clinical Research Network Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html ► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Sponsor: Lux Biosciences, Inc. Information: clinicaltrials@luxbio.com ► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis Sponsor: Merrimack Pharmaceuticals Information: (617) 441-1000 ► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema Sponsor: Rocky Mountain Retina Consultants/Genentech Information: study@rmrc.xohost.com ► Study: Study of Difluprednate in the Treatment of Uveitis Sponsor: Sirion Therapeutics Information: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

COMPLETED ENROLLMENT

► Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

► Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Contact: (800) 411-1222

► Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Contact: (800) 411-1222

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: Diabetic Retinopathy Clinical Research Network
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html

► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Sponsor: Lux Biosciences, Inc.
Information: clinicaltrials@luxbio.com

► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis
Sponsor: Merrimack Pharmaceuticals
Information: (617) 441-1000

► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor: Rocky Mountain Retina Consultants/Genentech
Information: study@rmrc.xohost.com

► Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Information: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

Retinal Physician, Issue: November 2008

Table of Contents