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

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJohn A Wells, III, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Palmetto Retina Center, LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility 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.

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Treatment Details

Interventions

Pegaptanib Sodium (Macugen) (Anti-VEGF Therapy)

Participant Groups

2Treatment groups

Active Control

Group I: Pegaptanib Sodium 0.3mg (Macugen)Active Control1 Intervention

Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

Group II: Pegaptanib Sodium 1 mg (Macugen)Active Control1 Intervention

Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.