Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palmetto Retina Center, LLC
• Collaborators: Eyetech Pharmaceuticals; Pfizer

Criteria

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 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 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 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.