Article Date: 5/1/2009

CLINICAL TRIAL UPDATE

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 age-related macular degeneration
Design: Nonrandomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment
Number of Patients: 40
Inclusion Criteria: 50 years of age or older with active subfoveal CNV secondary to AMD; central retinal thickness >300 μm; 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: EMERALD: Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis in Patients With Age-Related Macular Degeneration
Sponsor: MacuSight, Inc.
Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within 6 months of initial study visit, and may have been treated with up to 3 Lucentis (ranibizumab) or 3 Avastin (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve; visual acuity of 20/40 to 20/200 in the study eye
Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye; presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
Information: cdelpouys@macusight.com

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 choroidal neovascularization (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 (Lucentis or Avastin, subjects may have been treated previously with Macugen, but must have been most recently treated with Lucentis or Avastin and met the criteria for failure below) 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; subjects who have been previously diagnosed with Type 1 or Type 2 diabetes mellitus. Subjects who do not have a documented diagnosis but have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus; women of child-bearing potential (female subjects must be post-menopausal or surgically sterilized)
Information: clinicaltrials@neovistainc.com

Study: Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-Related Macular Degeneration
Sponor: 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; have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>8 diopters) or CNV secondary to other causes than AMD; any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy; any intraocular or general surgery, including cataract surgery, within 2 months of Day 1; history of uveitis in either eye; any ocular or periocular infection within 4 weeks prior to Day 1; active ocular inflammation grade trace and above; cup to disc ratio >0.8, IOP >21 mm Hg in glaucoma subjects treated with more than 2 ocular hypotensive agents; previous pars plana vitrectomy or trabeculectomy in study eye; history of anterior vitrectomy; inability to obtain photographs, FA or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access; aphakia
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; patients with a known sensitivity to any component of the formulations under investigation
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 periocular 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; participation in another simultaneous medical investigation or trial; media insufficient to obtain a view; other causes of CNV not related to AMD
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: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration
Sponsor: University of California, Davis/Genentech
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
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 ×325

Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Information: cawh@aol.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: 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: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Sponsor: CoMentis
Information: jmonk@comentis.com

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: ghafiz1@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 0.5mg/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 Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD)
Sponsor: Lahey Clinic
Information: Avon.P.Stewart@Lahey.org

Study: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
Sponsor: MacuSight, Inc.
Information: ebaj@retinalconsultantsaz.com

DRY AMD
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, dementia or neurodegenerative disorders; diagnosis or recent history of clinically significant cerebrovascular disease; uncontrolled hypertension; uncontrolled Type 1 or Type 2 diabetes mellitus
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 >0.5 and <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 (IOP >21 mm Hg OR concurrent therapy at screening with IOP-lowering agents) in either eye; treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye; any change in systemic steroid therapy within 3 months of screening
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

Study: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Sponsor: Allergan
Information: clinicaltrials@allergan.com

SCREENING
Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain polymorphisms predispose people to develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 μm; absence of other diagnostic criteria for AMD
Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of pupillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases)
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 treatment 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

RETINAL IMAGING STUDIES
Study: Retinal Imaging in Patients With Inherited Retinal Degenerations
Sponsor: University of California-San Francisco/University of California-Berkeley
Status: Enrolling patients
Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the AdaptiveOptics Scanning Laser Ophthalmoscope
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Number of Patients: 130
Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley
Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery
Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu

Study: Novel Diagnostics for Ocular Structure
Sponsor: University of Pittsburgh/National Institutes of Health
Status: Enrolling patients
Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called OCT
Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Number of Patients: 500
Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma
Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation
Information: Tammy J Capozzoli, (412) 647-2375, capozzolitj@upmc.edu

Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging
Sponsor: University of Pittsburgh
Status: Currently enrolling
Purpose: To evaluate OCT, an FDA-approved device used to image diseases of the eye
Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Number of Patients: 1500
Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and various other eye diseases. Also must be able to fixate on target.
Exclusion Criteria: Fundus not visible or opaque media
Information: (412) 647-2375

Study: Metabolic Mapping to Measure Retinal Metabolism
Sponsor: National Eye Institute
Status: Currently enrolling
Information: (800) 411-1222

DIABETIC MACULAR EDEMA
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 μm; 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: Non-Randomized, 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; participation in an investigational trial within 30 days of NIR participation that involved treatment with any drug that has not received regulatory approval at the time of study entry; major surgery within 28 days prior to participation or major surgery planned during the next 6 months
Information: hwhelan@mcw.edu

Study: DA VINCI: DME And VEGF Trap-Eye: INvestigation of Clinical Impact
Sponsor: Regeneron Pharmaceuticals/Bayer
Purpose: To study of efficacy and safety of VEGF Trap-Eye in subjects with diabetic macular edema
Design: Active Control, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Number of Patients: 200
Inclusion Criteria: Patients with clinically significant DME with central involvement; adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema; ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
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 or periocular corticosteroids in the study eye within 3 months of screening; previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening; uncontrolled diabetes mellitus; uncontrolled hypertension defined as systolic >180 mm Hg or >160 mm Hg on 2 consecutive measurements or diastolic >100 mm Hg on optimal medical regimen; ocular disorders in the study eye, other than DME, that may confound interpretation of study results
Information: maria.thurman@parexel.com

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 diabetic macular edema
Design: Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment
Number of Patients: 40
Inclusion Criteria: 18 years of age or older with diabetic macular edema, history of vitrectomy, central retinal thickness ≥275 μm, visual acuity 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, known allergy to the study medication, known steroid-responder, use of systemic steroids, female subjects that are pregnant, nursing or planning a pregnancy
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 Clinically Significant Diabetic Macular Edema
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@longisland retina.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
Purpose: To test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 300
Inclusion Criteria: Diabetic macular edema and VA between 20/50 and 20/200
Exclusion Criteria: Recent laser therapy in the eye; recent signs of uncontrolled diabetes; blood pressure worse than 160/100; severe cardiac disease
Information: (800) 718-1021

Study: Study of the Safety and Efficacy of a New Treatment for DME
Sponsor: Allergan
Information: clinicaltrials@allergan.com

Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
Information: (877) 285-4559

Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor: NEI/Genentech/Allergan
Information: (866) 372-7601

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: 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: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With DME
Sponsor: MacuSight, Inc.
Information: cdelpouys@macusight.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: 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, hemiretinal 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 μm using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within 1000 μm 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 μm of foveal center; likelihood of evidence-driven indication for peripheral photocoagulation in the next 6 months; patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of <15 letters of vision or thinning of the Center Point on OCT of <20% from baseline determination; prior grid laser within 4 months of baseline or more than 1 prior grid laser treatment; no prior intravitreous or periocular steroid injections in the study eye
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 retinal vein occlusion 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 <21 mm Hg with no more than 1 topical ocular antihypertensive agent; initially, patients with vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide >12 weeks prior to study entry, with an initial decrease in macular edema and improvement in VA and subsequent decline in VA accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a long-lasting response to a single intravitreal triamcinolone acetonide injection
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; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study; female patients who were pregnant or lactating or not taking precautions to avoid pregnancy
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, Non-randomized, 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; central macular edema present on clinical examination and OCT testing with a central point thickness >250 μm; visual acuity score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
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; exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (ie, subretinal fibrosis or geographic atrophy); any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
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

UVEITIS
Study: Uveitis Gene-expression Profiling
Sponsor: Oregon Health and Science University
Purpose:To quantitatively measure the expression of consistent alteration in peripheral blood from patients with more than 40000 gene sequences using microarray gene chip technology
Design: Case Control, Prospective
Number of Patients: 392
Exclusion Criteria: Special/vunerable subject populations (eg, mentally impaired persons and children) will not be enrolled
Information: rosenbaj@ohsu.edu

Study: Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Sponsor: Duke University/Childhood Arthritis and Rheumatology Research Alliance
Purpose: To examine the efficacy of infliximab for the treatment of persistent uveitis in children
Design: Active Control, Efficacy Study, Open Label, Parallel Assignment, Randomized, Treatment
Number of Patients: 40
Inclusion Criteria: Ages 4 to 18 years old; noninfectious uveitis; persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications; failure of at least 6 weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine; ability to provide informed consent (subject or parent/guardian); onset of uveitis <16 years of age; topical ophthalmologic treatments allowed; systemic corticosteroid use at entry may be allowed; willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion; concomitant methotrexate must be taken at time of initiation of infliximab; participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination; negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
Exclusion Criteria: Previous use of biologic medications for uveitis; intraocular steroid injection or ophthalmologic surgery within the preceding 3 months; uveitis due to trauma or intraocular surgery; females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion; males who plan on fathering a child within 6 months after their last infliximab infusion; history of a known allergy to murine products; documentation of seropositivity for human immunodeficiency virus (HIV); documentation of a positive test for hepatitis B surface antigen or hepatitis C; known history of a serious infection (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months; opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
Information: (919) 684-6575

Study: Adalimumab (Humira) in the Treatment of Refractory Non-Infectious Uveitis
Sponsor: Oregon Health and Science University
Purpose: To assess the safety and efficacy of adalimumab in uveitis
Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: Unavailable
Inclusion Criteria: Patients with vision-threatening autoimmune uveitis; failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects
Exclusion Criteria: Serious concomitant illness that could interfere with the subject's participation in the trial; previous or current use of cyclophosphamide; unable or unwilling to undergo multiple injections
Information: suhlere@ohsu.edu

Study: Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Sponsor: University of Miami/Genentech
Purpose: To determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis
Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study; age >18 years; non-infectious uveitis in study eye; stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator; vision 20/40 or worse in study eye; CME on fluorescein angiography (FA); OCT demonstrating thickness greater than 300 μm in the central subfield; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Criteria: Previous intravitreal triamcinolone injection in study eye within 3 months of study injection; use of more than 2 glaucoma medicines for study eye; significant epiretinal membrane as judged by treating physician; evidence of vitreomacular traction on OCT; previous vitrectomy in study eye; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch; any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous IND trial; treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study
Information: talbini@med.miami.edu

Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: Quality of Life and Visual Function in Uveitis Patients
Sponsor: New York Eye and Ear Infirmar
Information: (212) 979-4251

Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Sponsor: Novartis
Information: (862) 778-8300

Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: LIME: Lucentis for Inflammatory Macular Edema Trial
Sponsor: University of California, San Francisco/Genentech
Information: kevin.hong@ucsf.edu

Study: Safety, Tolerability, and Efficacy of AIN457 in the Treatment of Uveitis
Sponsor: Novartis
Information: (862) 778-8300

Study: Corticosteroid Implant vs. Oral Corticosteroid Treatment for Uveitis
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

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OTHER
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: Sensitivity of the Home Macular Perimeter (HMP)
Sponsor: Notal Vision Ltd
Information: osnat@notalvision.com

Study: Double-Masked Study of Safety and Efficacy of VEGF Trap-Eye in Subjects With DME
Sponsor: Regeneron Pharmaceuticals/Bayer
Information: maria.thurman@parexel.com

Study: DETAIL: Lucentis for Age-Related Macular Degeneration Pigment Epithelial Detachments
Sponsor: Pacific Eye Associates/Genentech
Information: annefungmd@yahoo.com

Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME
Sponsor: ThromboGenics
Information: (212) 201-0920 ×277


Retinal Physician, Issue: May 2009