drugset / Trial / NCT00486018

A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)

NCT00486018

Phase 3 Completed 397 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Timeline

Start
2007-07
Primary completion
2009-05
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.3 mg Other
Subject Ranibizumab Monoclonal antibody 0.5 mg Other