Status:
COMPLETED
Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Lead Sponsor:
Palmetto Retina Center, LLC
Collaborating Sponsors:
Pfizer
Eyetech Pharmaceuticals
Conditions:
Branch Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this 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). We hypothe...
Detailed Description
Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to...
Eligibility Criteria
Inclusion
- 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 visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method.
- Central foveal thickness greater than or equal to 250 microns using the OCT-3
- Less than 25% of foveal capillary ring disruption
- Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal center
- Absence of hemorrhage or lipid in the foveal center
- Investigator comfortable deferring macular laser for 18 weeks from baseline and intravitreous steroid for 36 weeks from baseline
Exclusion
- 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 microns 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 one prior grid laser treatment.
- No prior intravitreous or periocular steroid injections in the study eye.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00406107
Start Date
January 1 2006
End Date
April 1 2008
Last Update
September 12 2014
Active Locations (3)
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1
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
2
Cumberland Valley Retina Center
Hagerstown, Maryland, United States, 21740
3
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169