A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
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
Outcome
Met primary endpoint
registry Sham Injection vs Ranibizumab Injection 0.3 mg; p <0.0001; Difference in Least Squares means 9.4 (95% CI 6.6 to 12.2) NCT00486018 ↗
registry Sham Injection vs Ranibizumab Injection 0.5 mg; p <0.0001; Difference in Least Squares means 10.6 (95% CI 7.6 to 13.6) NCT00486018 ↗
Publications
- Suner IJ, Bressler NM, Varma R, Lee P, Dolan CM, Ward J, Colman S, Rubio RG. Reading speed improvements in retinal vein occlusion after ranibizumab treatment. JAMA Ophthalmol. 2013 Jul;131(7):851-6. doi: 10.1001/jamaophthalmol.2013.114.
- Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.3 mg | Other |
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Other |