Conditions: Macular Edema Retinal Vein Occlusion
Keywords: Lucentis RVO BRVO Edema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 397
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Ranibizumab injection 0.3 mg intervention 2: Ranibizumab injection 0.5 mg intervention 3: Sham injection
Intervention descriptions: intervention 1: Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 2: Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 3: Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.

Protocol document: