drugset / Trial / NCT00407355

Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

NCT00407355

Phase 1/2 Completed 40 enrolled Peter A Campochiaro, MD Genentech, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide benefit in patients with macular edema due to branch vein occlusions, but several laser treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser photocoagulation does not provide benefit for macular edema due to central vein occlusions 2. Therefore, new treatments are needed.The objective of this study is to assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels. The purpose of this research protocol is pilot study to determine if a randomized placebo controlled trial is warranted.

Timeline

Start
2006-01
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ranibizumab Monoclonal antibody 0.3 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal