Article Date: 9/1/2009

CLINICAL TRIAL UPDATE

DRY AMD

► Study: COMPLETE: Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD) Sponsor: University of Miami/Alexion Pharmaceuticals Purpose: To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria: In the study eye(s), the presence of non-exudative AMD documented by fundus photography, autofluorescence, fluorescein angiography, and spectral domain OCT; visual acuity of 20/63 Exclusion Criteria: Visual acuity worse than 20/63; Any history of choroidal neovascularization in the study eye; Unresolved meningococcal disease; Confounding ocular conditions such as amblyopia; aphakia; myopia requiring >6 D of correction Information: (305) 326-6148 ► Study: TORPA: Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration Sponsor: Graham Merry, MD Purpose: To evaluate clinical outcomes of Photobiomodulation treatment on patients with dry AMD Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Best corrected visual acuity between 20/40 and 20/200 Exclusion Criteria: Visually significant cataracts; presence of a visually significant posterior capsule if prior cataract has been performed Information: (865) 483-6399 ► Study: GAP: The Natural History of Geographic Atrophy Progression Study Sponsor: Alcon Research Purpose: To evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time Design: Case-only, Prospective Number of Patients: 1000 Inclusion Criteria: Clinical diagnosis of geographic atrophy secondary to AMD with no CNV lesion Information: petra.kozma@alconlabs.com ► Study: Sirolimus to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration Sponsor: National Eye Institute Purpose: To examine the safety and effectiveness of sirolimus in preserving vision in patients with geographic atrophy (GA) associated with AMD 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. Exclusion Critieria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (eg, diabetic retinopathy with IO or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia Information: (800) 411-1222 ► Study: A Multi-Center Study of Reading Rehabilitation in Macular Disease Sponsor: Department of Veteran Affairs Purpose: To measure the effectiveness of a newly-designed oculomotor training program for patients with macular disease, including AMD Design: Randomized, Double Blind (Subject, Outcomes Assessor), Crossover Assignment, Efficacy Study Number of Patients: 120 Inclusion Criteria: Patients with a diagnosis of macular disease, such as AMD; an established preferred retinal locus; VA of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye) Exclusion Criteria: Other major ophthalmologic and neurologic disease, CNV, moderate to severe media opacities Information: pdgrant@uic.edu ► Study: GATE: Geographic Atrophy Treatment Evaluation Sponsor: Alcon Research Purpose: To evaluate AL-8309B as a topical ocular treatment for geographic atrophy secondary to AMD Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment Number of Patients: 550 Inclusion Criteria: Patient must state the ability to administer eye drops or have a caretaker to administer the eye drops; well-demarcated area of atrophy secondary to AMD if the lesion is multifocal Exclusion Criteria: Ocular disease in the study eye that in the opinion of the Investigator may confound assessment of the retina or affect central vision, other than non-exudative AMD Information: medical.information@alconlabs.com ► Study: Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration Sponsor: Pfizer Purpose: To determine the safety and tolerability of RN6G in patients with dry AMD Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study Number of Patients: 45 Inclusion Criteria: Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement; BCVA of 20/320 or better in the worst eye Exclusion Criteria: Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions; diagnosis or history of Alzheimer's disease, Information: (800) 718-1021 ► Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy Sponsor: Alimera Sciences Purpose: To compare the safety and efficacy of Medidur FA treatment in 1 eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 40 Inclusion Criteria: Clinical diagnosis bilateral GA secondary to AMD of >0.5and <7 MPS disc areas; males and non-pregnant females 55 years old or older Exclusion Critieria: GA secondary to any condition other than AMD in either eye; history of or current CNV in either eye or the need for antiangiogenic therapy; glaucoma or ocular hypertension Information: lschulz@med.wayne.edu ► Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration Sponsor: The New York Eye and Ear Infirmary Information: ktai@nyee.edu ► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration Sponsor: Ocular Transplantation; National Neurovision Research Institute 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. 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 Information: lschulz@med.wayne.edu

WET AMD

► Study: Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-VEGF in Subjects With Wet Age-Related Macular Degeneration Sponsor: Allergan Purpose: To evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to AMD Design: Treatment, Nonrandomized, Open Label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 40 Inclusion Criteria: 50 years of age or older with active subfoveal CNV secondary to AMD; central retinal thickness ≥ 300 m; visual acuity between 20/400 and 20/32; eligible for Anti-VEGF therapy Exclusion Criteria: Previous treatment for CNV due to AMD; high eye pressure; glaucoma; uncontrolled systemic disease; known allergy to the study medications; recent eye surgery or injections in the eye Information: clinicaltrials@allergan.com ► Study: A Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration Sponsor: Genentech Purpose: To study the efficacy and safety of ranibizumab injection administered intravitreally to patients with CNV secondary to AMD Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment Number of Patients: 1100 Inclusion Criteria: CNV lesions with classic CNV component, occult CNV, or with some classic CNV component are permissible Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; prior treatment with Visudyne, external-beam radiation therapy, or TTT in the study eye Information: lane.hayley@gene.com ► Study: A Phase 1 Ascending and Parallel Group Trial to Establish the Safety Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corporation Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to AMD Design: Treatment, Nonrandomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study Number of Patients: 50 Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD (ie, predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram Exclusion Criteria: Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals; previous or concomitant therapy with intravitreous corticosteroids; diabetic retinopathy; history or evidence of severe cardiac disease Information: (212) 845-8214 ► Study: Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab Sponsor: National Eye Institute Purpose: To measure antibody levels in the blood of people with bleeding or swelling in the retina who have or have not been treated with bevacizumab or ranibizumab Design: Prospective Number of Patients: 30 Inclusion Criteria: Subjects will include adults being treated for exudative AMD, or macular edema secondary to DR or venous occlusion Exclusion Criteria: Patients who are currently receiving any form of systemic immunosuppressive or immunomodulatory therapy, including corticosteroids; patients who have autoimmune or rheumatologic disease; patients with evidence of active systemic infection Information: prpl@mail.cc.nih.gov ► Study: ROSE: A Study to Evaluate the Neovista Ophthalmic System for the Treatment of Subfoveal CNV in Patients With AMD That Have Failed Primary Anti-VEGF Therapy Sponsor: NeoVista Purpose: To evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal CNV in patients with age-related macular degeneration that have failed primary anti-VEGF therapy Design: Treatment, Nonrandomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Subjects 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 (including blood, scarring, and neovascularization) of <12 total disc areas (21.24 mm2), and a GLD ≥5.4 mm; subjects must have received a minimum of 3 prior injections (a minimum of 3 prior injections of the same compound) of anti-VEGF therapy with evidence of “failure” to respond to therapy; subjects must be age 50 or older Exclusion Criteria: Subjects with prior or subfoveal CNV therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (TTT) (Note: This includes subjects with no known history, but with photographic evidence of prior therapy); subjects who underwent previous radiation therapy to the eye, head or neck Information: clinicaltrials@neovistainc.com ► Study: Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-Related Macular Degeneration Sponsor: Lpath, Inc. Purpose: To assess the safety of iSONEP, which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P) Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 33 Inclusion Criteria: 50 years and older; BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/ 70-20/400); any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT; visual acuity in fellow eye must be 20/800 or better at 4 meters Exclusion Criteria: Ocular disease other than CNV that could compromise vision in study eye; systemic immunosuppressive medication/therapy (eg, chemotherapy, steroids); uncontrolled hypertension and/or arrhythmias; QT/QTc interval measurement >450 msec; cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ Information: (270) 554-8929 ► Study: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration Sponsor: Retina Macula Institute Purpose: To assess 2 groups (monthly and PRN therapy) and assess high resolution OCT microperimetry, and Multi-focal ERG outcomes Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment Number of Patients: 45 Inclusion Criteria: Age ≥50 years old; patients with active neovascular AMD Exclusion Criteria: Participation in another simultaneous medical investigation or trial; concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous PDT therapy; previous intravitreal steroid therapy within last 3 months; previous anti-VEGF therapy in the past month Information: lillian.rmi@gmail.com ► Study: Combination Ranibizumab and Bromfenac for Neovascular Age-Related Macular Degeneration Sponsor: Oregon Health and Science University/Genentech Purpose: To determine whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Age >50 years; patients with active neovascular AMD; if the patient has bilateral disease and qualifies for the study, both eyes may be included Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous intravitreal steroid or anti-VEGF therapy within last 3 months; patients with a concurrent corneal epithelial disruption or erosion; patients with immune deficiencies that would affect the ability of the cornea to heal Information: schainm@ohsu.edu ► Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab Sponsor: Retina Center, Minnesota/Genentech Purpose: To focus on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD Design: Case-Only, Prospective Number of Patients: 10 Inclusion Criteria: Patients to be included in the study must have AMD with choroidal neovascularization; BCVA between 20/20 and 20/400; lesion size less than or equal to 12 MPS disc areas Exclusion Criteria: Media insufficient to obtain a view; other causes of CNV not related to AMD; active ocular or peri-ocular infection; ocular surgery within 1 month prior to the study; any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Information: vu@retinadocs.com ► 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 Information: (866) 622-8436 ► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration Sponsor: Novartis/Greater Houston Retinal Research Information: http://www.houstonretina.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. 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 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. 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 Information: (503) 494-3616 ► Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD Sponsor: NeoVista Information: (510) 933-7650, info@neovistainc.com ► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1) Sponsor: Regeneron/Bayer 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 Information: (919) 226-1440 x325 ► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST) Sponsor: Retina Vitreous Associates, P.C.; Genentech Information: cawh@aol.com ► 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. Information: denise.teuber@ophthotech.com ► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial Sponsor: National Eye Institute Information: dan.martin@emory.edu ► Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration Sponsor: National Eye Institute Information: (800) 411-1222 ► Study: The MAP Study: FA/Medidur for AMD Pilot Sponsor: Johns Hopkins University/Alimera Sciences Information: ghafizl@jhmi.edu ► Study: Antioxidant Systems and Age-Related Macular Degeneration Sponsor: Vanderbilt University/National Institutes of Health 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 Information: prpl@mail.cc.nih.gov ► 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 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 Information: (918) 747-7799 ► Study: Pilot Study Red uced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD) Sponsor: Lahey Clinic Information: Avon.P.Stewart@Lahey.org

DIABETIC MACULAR EDEMA

► Study: Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema Sponsor: iCo Therapeutics Inc. Purpose: To evaluate the safety and tolerability of 4 different doses of iCo-007 Intravitreal Injection in patients with diffuse DME Design: Treatment, Open Label, Single Group Assignment, Safety Study Number of Patients: 15 Inclusion Criteria: Confirmed diagnosis of diabetes mellitus type 1 or 2 (both, insulin or non-insulin dependent); subjects who have moderate to severe non-proliferative diabetic retinopathy (NPDR), as defined by ETDRS criteria, and diffuse DME within 300 m from the center of the macula in the study eye (with or without cystoid changes) confirmed by FA Exclusion Criteria: Subjects with macular or perimacular edema secondary to an etiology other than diabetes mellitus; subjects with concurrent retinal diseases or conditions in the study eye (including conditions requiring urgent PRP), glaucoma (or ocular hypertension), retinal vascular occlusion, exudative AMD (drusen permitted), tear (rip) of the RPE, a vitelliform-like lesion of the outer retina (eg, pattern dystrophies or basal laminar drusen) Information: nidia.rosado@duke.edu ► Study: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients Sponsor: Alcon Research Purpose: To determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment Number of Patients: 260 Inclusion Criteria: Patients with nonproliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification Exclusion Criteria: Central subfiled macular thickness >250 m; CME in either eye Information: (888) 451-3937 ► Study: Near-Infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study Sponsor: Medical College of Wisconsin Purpose: To examine the use of NIR because it has been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a low cost of treatment, and it may serve as an effective, noninvasive alternative or adjunctive treatment to laser photocoagulation, the current standard of care for DME Design: Nonrandomized, Open Label, Safety/ Efficacy Study, Single Group Assignment, Treatment Number of Patients: 20 Inclusion Criteria: Age ≥18 years Subjects <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable; diagnosis of diabetes mellitus (type 1 or type 2); at least 1 eye meets the study eye criteria; fellow eye meets criteria; any candidate identified by a study investigator as being able to successfully tolerate a 3-month deferral of laser photocoagulation Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled Information: hwhelan@mcw.edu ► Study: Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema Sponsor: Allergan Purpose: To evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with DME Design: nonrandomized, Open Label, Safety/ Efficacy Study, Single Group Assignment, Treatment Number of Patients: 40 Inclusion Criteria: 18 years of age or older with DME, history of vitrectomy, central retinal thickness ≥275 m, VA between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye Exclusion Criteria: Known anticipated need for ocular surgery during the study period, history of glaucoma or current high eye pressure requiring more than 1 medication, uncontrolled systemic disease Information: clinicaltrials@allergan.com ► Study: Study Comparing Two Doses of Ranibizumab in the Treatment of Clinically Significant Diabetic Macular Edema Sponsor: Long Island Vitreoretinal Consultants Purpose: To evaluate the safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5 mg ranibizumab to those receiving 1.0 mg ranibizumab Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 50 Inclusion Criteria: Type 1 or Type 2 diabetic subjects; vision between 20/20 and 20/400; presence of CSDME Exclusion Criteria: Presence of any condition that would prevent clear visualization of the back of the eye; uncontrolled glaucoma; inflammation inside the eye; certain prior eye surgeries, other than cataract surgery; other eye diseases that may compromise the vision in the study eye Information: mschlameuss@longislandretina.com ► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy Sponsor: NEI/Genentech/Allergan Information: (866) 372-7601 ► Study: Safety and Tolerability of NOVA63035 “Corticosteroid” in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy Sponsor: Novagali Pharma mourad.amrane@novagali.com ► Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II) Sponsor: Genentech/Michael J. Jumper Information: jrose@westcoastretina.com ► Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR) Sponsor: Retina Research Foundation Information: (518) 533-6550 ► Study: Sirolimus to Treat DME Sponsor: National Eye Institute Information: (800) 411-1222 ► Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With DME Sponsor: Pfizer 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 DME Sponsor: Bp Consulting, Inc. Information: michelle-bpconsulting@yahoo.com

RETINAL VEIN OCCLUSION

► Study: Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) Sponsor: Regeneron Pharmaceuticals/Bayer Purpose: To determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 165 Inclusion Criteria: Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 m on OCT; ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye Exclusion Criteria: Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.); prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye Information: suzanne.bates@parexel.com ► Study: A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion Sponsor: Duke University/Bausch & Lomb, Inc. Purpose: To determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of CRVO that has caused persistent macular edema and decreased visual acuity Design: Treatment, Nonrandomized, Open Label, Single Group Assignment Number of Patients: 30 Inclusion Criteria: A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation Information: (919) 684-4458 ► Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat Retinal Vein Occlusions Sponsor: Palo Alto Medical Foundation Status: Currently enrolling Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye Design: Treatment, Nonrandomized, Open-label, Active-control, Single-group Assignment, Safety/Efficacy Study Number of Patients: 68 Inclusion Criteria: Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion Exclusion Criteria: Active gout or high levels of uric acid Information: gaynonM@pamf.org ► Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion Sponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals Status: Currently enrolling Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/ Efficacy Study Number of Patients: 30 Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS VA 20/40 to 20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness ≥250 m using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within IOOO m of the foveal center; absence of hemorrhage or lipid in the foveal center Exclusion Criteria: Ocular conditions other than BRVO-related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months; significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 m of foveal center Information: jackwells@palmettoretina.com ► Study: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO) Sponsor: Duke University; Bausch & Lomb Status: Currently enrolling Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of RVO that has caused persistent macular edema and decreased visual acuity Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT; macular edema at least 1 disc area in size that involved the fovea; males and nonpregnant females at least 18 years of age; IOP controlled at <2l mm Hg with no more than 1 topical ocular antihypertensive agent; initially Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status Information: (919) 684-4458 ► Study: Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech Status: Enrolling patients Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema Design: Treatment, Nonrandomized, Open Label, Active Control, Single Group Assignment, Safety Study Number of Patients: 45 Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head Exclusion Critieria: Participation in another simultaneous ocular investigation or trial; uncontrolled hypertension; a condition that, in the opinion of the investigator would preclude participation in the study (ie, chronic alcoholism, drug abuse); significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy Information: (212) 452-6965 ► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion Sponsor: Greater Houston Retina Research Information: (713) 524-3434

OTHER

► Study: BEAT-ROP: Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity Sponsor: The University of Texas Health Science Center, Houston Purpose: To determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular phase of retinopathy of prematurity (ROP) compared to a control group receiving conventional laser therapy Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/ Efficacy Study Number of Patients: 150 Inclusion Criteria: Infants who have been screened by the AAO, AAP, and the AAPOS guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II Exclusion Criteria: Infants who have a congenital systemic anomaly or have a congenital ocular abnormality; infants who cannot be treated by conventional laser therapy because of problems with media clarity Information: Helen.A.Mintz-Hittner@uth.tmc.edu ► Study: BLOCK-ROP: Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity Sponsor: Vision Research Foundation Purpose: To evaluate bevacizumab for safety and efficacy in treatment of retinopathy of prematurity Design: Treatment, Open Label, Single Group Assignment, Safety Study Number of Patients: 22 Inclusion Criteria: Premature newborn infants with bilateral progressive APROP despite complete peripheral retinal ablation; inborn babies at participating NICUs; outborn babies transferred to participating NICU Exclusion Criteria: Fatal systemic anomaly; an ocular anomaly of one or both eyes affecting the retina or choroid; an ocular anomaly precluding use of the RetCam Information: (248) 288-2280 ► Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration Sponsor: Ophthalmic Consultants of Boston/Genentech Information: jbankert@eyeboston.com

COMPLETED ENROLLMENT

► Study: Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-VEGF in Subjects With Wet Age-Related Macular Degeneration Sponsor: Allergan Information: clinicaltrials@allergan.com ► Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With DME Sponsor: MacuSight, Inc. Information: cdelpouys@macusight.com ► Study: A Multi-Center Trial to Evaluate the Safety and Efficacy of Pegaptanib Sodium (Macugen) Injected Into the Eye Every 6 Weeks for up to 2 Years for Macular Swelling Associated With Diabetes Sponsor: Pfizer Information: (800) 718-1021 ► Study: EMERALD: Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis in Patients With Age-Related Macular Degeneration Sponsor: MacuSight, Inc. Information: cdelpouys@macusight.com ► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD Sponsor: GlaxoSmithKline Information: (877) 379-3718 ► Study: DA VINCI: DME And VEGF Trap-Eye: INvestigation of Clinical Impact Sponsor: Regeneron Pharmaceuticals/ Bayer Information: maria.thurman@parexel.com ► Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema Sponsor: Eli Lilly and Company Information: (877) 285-4559 ► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From DME Sponsor: Allergan Information: clinicaltrials@allergan.com ► Study: Study of the Safety and Efficacy of a New Treatment for DME Sponsor: Allergan Information: clinicaltrials@allergan.com

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Retinal Physician, Issue: September 2009