Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

NCT01976338 ↗

Phase 3 Completed 283 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Timeline

Start: 2013-11-12
Primary completion: 2016-03-28
Completion: 2016-03-28

Outcome

Met primary endpoint

paper Compared with sham, ranibizumab treatment resulted in superior VA gains. PMID 31902472 ↗

paper LS mean difference between ranibizumab vs. sham: +7.5 letters [95% confidence interval, 5.5-9.5], 1-sided P < 0.001). PMID 31902472 ↗

Publications

Wei W, Weisberger A, Zhu L, Cheng Y, Liu C; BLOSSOM Study Group. Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study. Ophthalmol Retina. 2020 Jan;4(1):57-66. doi: 10.1016/j.oret.2019.08.001. Epub 2019 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal