Bay Area Retina Associates
Bay Area Retina Associates
Bay Area Retina Associates
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Current BARA Clinical Trials

Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
OMASPECT Sponsor: Hoffmann-La Roche Year: 2016
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study, Sponsor: Genentech Roche.
 
A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 28-Week Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally In Patients with Diabetic Macular Edema
BOULEVARD Sponsor: Hoffmann-La Roche Year: 2016
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, 28-week study in participants with CI-DME. There are three parallel groups and total duration of the study will be approximately 32 weeks.
 
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
PAVE Sponsor: Santen, Inc. Year: 2015
A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration.
 
A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
AVENUE Sponsor: Hoffmann-La Roche Year: 2015
A multiple-center, multiple-dose and regimen, randomized, active comparator controlled, double-masked, parallel group, 36 week study to investigate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 administered intravitreally in patients with choroidal neovascularization secondary to age-related macular degeneration.
 
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
SPECTRI Sponsor: Hoffmann-La Roche Year: 2014
This study is a phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
 
Prompt Panretinal Photocoagulation versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
DRCR Protocol S Sponsor: Diabetic Retinopathy Clinical Research Network Year: 2012
The primary objective of the phase III clinical trial is to determine if visual acuity outcomes at two years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.
 

Recent BARA Clinical Trials

A Safety and Efficacy Study of DE-120 Injectable Solution for Age-Related Macular Degeneration
VAPOR1 Sponsor: Santen, Inc Year: 2015
A multicenter, randomized, open label, phase IIa study assessing the efficacy, safety, and duration of effect of intravitreal injections of DE-120 as monotherapy and with a single Eylea® injection in subjects with treatment-naive exudative age-related macular degeneration.
 
Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC
STOMP-CSC Sponsor: Roger Goldberg, M.D., M.B.A. (IST) Year: 2015
The objective of the phase II, randomized, double-masked, dose-ranging study is to assess the efficacy and safety of mifepristone 300- or 900-mg once daily dosing by mouth for 4 weeks, in patients with central serous chorioretinopathy (CSC).
 
Effect of Diabetes Education during Retinal Ophthalmology Visits on Diabetes Control
REINFORCE Sponsor: Allergan Year: 2014
The objective of this study is to better understand the use of Ozurdex in real world clinical practice for the treatment of DME (i.e. real-world effectiveness and safety data for the treatment of Ozurdex as both monotherapy and combination therapy in both treatment naïve and previously treated DME patients.
 
Genetics Ancillary Study
Genetics Ancillary Study Sponsor: Diabetic Retinopathy Clinical Research Network Year: 2012
The purpose of this project is to create a repository of at least 2000 current DRCR.net study participant’s blood samples with extracted genetic materials and clinical phenotype information as a resource for the research.
 
Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good Visual Acuity
DRCR Protocol V Sponsor: Diabetic Retinopathy Clinical Research Network Year: 2013
The primary objective of the phase III clinical trial is to compare the percentage of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive prompt focal/grid photocoagulation + deferred anti-VEGF, observation + deferred anti-VEGF, or prompt anti-VEGF.
 
A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab, for Diabetic Macular Edema
DRCR Protocol T Sponsor: Diabetic Retinopathy Clinical Research Network Year: 2012
The primary purpose of the phase III clinical trial is to compare the efficacy and safety of intravitreal aflibercept, intravitreal bevacizumab, and intravitreal ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to 20/320. Prioritizing resources from a public health policy perspective could be easier if more precise estimates regarding the risks and benefits of other anti-VEGF therapies were available, especially when the difference in costs could be billions of dollars over just a few years. Thus, there is a clear rationale at this time to explore potential anti-VEGF alternatives to ranibizumab that might prove to be as or more efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost substantially less. Of the potentially available alternative anti-VEGF agents for this trial, bevacizumab and aflibercept are the best candidates for a direct comparison study.
 
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)
OASIS Sponsor: ThromboGenics Year: 2011
This study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA) including macular hole.
 
A Phase II Evaluation of Topical NSAIDs in Eyes with Non-central Involved Diabetic Macular Edema
DRCR Protocol R Sponsor: DRCR Network Year: 2011
This study is being conducted to assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central DME. This phase II trial may provide proof of concept evidence that topical NSAID treatment can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non central-involved DME into the central subfield of the macula. Furthermore, it could determine the correlation between OCT and fundus photographic documentation of progression of DME into the central subfield in this clinical trial setting.
 
Effect of Diabetes Education during Retinal Ophthalmology Visits on Diabetes Control
DRCR Protocol M Sponsor: DRCR Network Year: 2011
The purpose of this phase III study is to assess whether glycemic control, assessed with HbA1c measurement, in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.
 
A Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Patients With Painful Diabetic Peripheral Neuropathy
VMDN-002 Sponsor: ViroMed Co., Ltd. Year: 2010-2012
The purpose of this phase I/ Phase II study is to assess the safety and tolerability of injecting VM202 in the leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with diabetic neuropathy.
 
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
DRCR Protocol N Sponsor: National Eye Institute Year: 2010
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy. This is a prospective, multi-center randomized clinical trial for patients with type 1 or 2 diabetes in which the study eye has vitreous hemorrhage precluding treatment with laser photocoagulation. Study eyes are randomized to intravitreal injection of 0.5mg ranibizumab (Lucentis) at baseline, 4 and 8 weeks versus saline injection at the same time periods.
 
An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery
DRCR Protocol Q Sponsor: National Eye Institute Year: 2009
An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery. The objective of the study is to determine the incidence of progression to center-involved macular edema 16 weeks after cataract surgery in eyes with diabetic retinopathy and without definite center-involved DME. All treatment is given at the discretion of the treating physicians.
 
A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery
DRCR Protocol P Sponsor: National Eye Institute Year: 2009
A Pilot Study in Individuals with Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery. Observational data is collected for eyes with center-involved DME undergoing cataract surgery with treatment given per investigator discretion, with a goal of determining feasibility of a future randomized trial.
 
A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD
Lucedex Sponsor: Bay Area Retina Associates Year: 2007
A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD (Lucedex). A prospective, single masked comparative trial using either combination therapy (group 1): same day combination therapy with 0.05cc intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection for four consecutive months will be compared to monotherapy (group 2): one intravitreal injection of 0.5 mg ranibizumab also given for four consecutive months. These treatments will then be followed by PRN treatment.
 
Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration
PDex Sponsor: Bay Area Retina Associates Year: 2006
Combination Triple Therapy (Dexamethasone, Photodynamic Therapy and Lucentis) vs. Lucentis Monotherapy. Patients affected by exudative AMD with subfoveal choroidal neovascularization (CNV) were randomized to one of two groups: Group 1 received ranibizumab monotherapy received injections every four weeks for the duration of the study; and Group 2 received triple therapy initially, followed by intravitreal ranibizumab every four weeks on indication.
 
A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration
siRNA Phase I Study Sponsor: Quark Pharmaceuticals Year: 2007
A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD). This study assessed the safety and tolerability of a single intravitreal injection of Sirna-027 (AGN211745) along with anatomical changes in the retina, changes in CNV, and changes in visual acuity.
 
A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
BRAVO Sponsor: Genentech Year: 2007
A Phase III multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection compared with sham in subjects with macular edema secondary to branch retinal vein occlusion.
 
A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion
CRUISE Sponsor: Genentech Year: 2007
A Phase III multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection compared with sham in subjects with macular edema secondary to central retinal vein occlusion.
 
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
RIDE Sponsor: Genentech Year: 2007
A Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab injection in patients with clinically significant macular edema secondary to Type 1 or 2 diabetes mellitus.
 
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
RISE Sponsor: Genentech Year: 2007
A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RISE). A Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab injection in patients with diabetic macular edema secondary to Type 1 or 2 diabetes mellitus.
 
A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
SAILOR Sponsor: Genentech Year: 2005
A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD). A Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.
 
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
DRCR Protocol J Sponsor: National Eye Institute Year: 2007
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy. Study eyes were randomized to one of the following: Intravitreal injection of 0.5 mg ranibizumab (Lucentis) at baseline and 4 weeks; Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks; Sham injection at baseline and 4 weeks.
 
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema
DRCR Protocol I Sponsor: National Eye Institute Year: 2007
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema. Study eyes were randomized to one of the following: Group A: Sham injection plus focal (macular) photocoagulation; Group B: 0.5 mg injection of intravitreal ranibizumab plus focal photocoagulation; Group C: 0.5 mg injection of intravitreal ranibizumab plus deferred focal laser photocoagulation; Group D: 4 mg intravitreal triamcinolone plus focal photocoagulation.
 
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
DRCR Protocol H Sponsor: National Eye Institute Year: 2005-08
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin). Study eyes were randomized to laser photocoagulation; 1.25mg intravitreal bevacizumab injection at baseline and 6 weeks; 2.5mg intravitreal bevacizumab injection at baseline and 6 weeks; 1.25mg intravitreal bevacizumab injection at baseline and (sham injection at 6 weeks); 1.25mg intravitreal bevacizumab injection at baseline, laser photocoagulation at 3 weeks, and 1.25mg intravitreal bevacizumab injection at 6 weeks.
 
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema
DRCR Protocol E Sponsor: National Eye Institute Year: 2004-07
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema. Phase 2 randomized, multi-center clinical trial in which one study eye was randomized to focal laser photocoagulation; posterior peribulbar injection of 40mg triamcinolone, anterior peribulbar injection of 20mg triamcinolone, posterior peribulbar injection of 40mg triamcinolone followed after one month by laser, or anterior peribulbar injection of 20mg triamcinolone followed after one month by laser. If both eyes qualified, then one eye received laser and the other eye was randomized to one of the four triamcinolone groups.
 
Evaluation of Vitrectomy for Diabetic Macular Edema Study
DRCR Protocol D Sponsor: National Eye Institute Year: 2004-09
Evaluation of Vitrectomy for Diabetic Macular Edema. Prospective nonrandomized treatment study in which vitrectomy was performed by the investigator's usual routine with one year of data collected to provide information on the following outcomes in eyes with diabetic macular edema that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.
 
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
DRCR Protocol B Sponsor: National Eye Institute Year: 2004-08
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema. One study eye was randomly assigned to one of three treatment groups: laser photocoagulation; 1mg intravitreal triamcinolone acetonide injection; or 4mg intravitreal triamcinolone acetonide injection. For patients with two study eyes, the second eye was randomly assigned to one of the two treatments not assigned to the first eye.
 
A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
DRCR Protocol A Sponsor: National Eye Institute Year: 2003-08
Laser Photocoagulation for Diabetic Macular Edema Study. This pilot study compared standard laser treatment with a similar laser treatment that was milder in intensity but greater in number of treatment spots ("mild macular grid" method).
 
Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study
SCORE Sponsor: National Eye Institute Year: 2004
Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE). A Phase III Study comparing the efficacy and safety of intravitreal injection of triamcinolone acetonide with stadard care in the treatment of macular edema from retinal vein occlusoin. SCORE included two separate trials: one for eyes with branch retinal vein occlusion and one for eyes with central retinal vein occlusion.
 
A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
PIER Sponsor: Genentech Year: 2005
A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With or Without Classic CNV Secondary to Age Related Macular Degeneration.
 
A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration
MARINA Sponsor: Genentech Year: 2003
A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration.
 
RhuFab V2 Ocular Treatment Combining the Use of Visudyne to Evaluate Safety
FOCUS Sponsor: Genentech Year: 2003
A Phase I/II, Single-Masked, Multicenter Study of the Safety, Tolerability, and Efficacy of Multiple-Dose Intravitreal Injections of rhuFab V2 in Combination With Verteporfin (Visudyne(R)) Photodynamic Therapy in Subjects With Neovascular Age Related Macular Degeneration.
 

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