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A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
August 1, 2011
Clinical trial
Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study.
Brown DM, Campochiaro PA, Bhisitkul RB, Ho AC, Gray S, Saroj N, Adamis AP, Rubio RG, Murahashi WY.
Main finding: Ranibizumab is an effective treatment for macular edema after BRVO.
- Purpose: To assess efficacy and safety of intravitreal ranibizumab in patients with macular edema following branch retinal vein occlusion
- Study type: Randomized controlled trial
- Condition: Branch retinal vein occlusion
Participants: ≥18 yo with centre-involving macular oedema secondary to BRVO, BCVA 20/40-20/400, mean central subfield thickness ≥250 μm
n=397
Intervention:
Group 1: Intravitreal Ranibizumab 0.3mg
Group 2: Intravitreal Ranibizumab 0.5mg
Group 3: Sham
Rescue laser available in all groups if criteriae met.
After 6 months, all patients with BCVA ≤20/40 or central subfield thickness ≥250 μm received ranibizumab.
Outcomes | Time point | RAN 0.3mg | RAN 0.5mg | Sham (RAN after 6mo) |
---|---|---|---|---|
Mean BCVA change (letter) | 6 months | +16.6 | +18.3 | +7.3 |
12 months | +16.4 | +18.3 | +12.1 | |
Gained ≥15 letters in BCVA | 6 months | 55.2% | 61.1% | 28.8% |
12 months | 56.0% | 60.3% | 43.9% | |
BCVA ≥20/40 | 6 months | 67.9% | 64.9% | 41.7% |
Reduction in CFT | 6 months | 337um | 345um | 158um |
June 1, 2010
Clinical trial
Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study.
Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG.
Main finding: Ranibizumab is an effective treatment for macular edema after BRVO.
- Purpose: To assess efficacy and safety of intravitreal ranibizumab in patients with macular edema following branch retinal vein occlusion
- Study type: Randomized controlled trial
- Condition: Branch retinal vein occlusion
Participants: ≥18 yo with centre-involving macular oedema secondary to BRVO, BCVA 20/40-20/400, mean central subfield thickness ≥250 μm
- n=397
Intervention:
Group 1: Intravitreal Ranibizumab 0.3mg
Group 2: Intravitreal Ranibizumab 0.5mg
Group 3: Sham
Rescue laser available in all groups if criteriae met.
After 6 months, all patients with BCVA ≤20/40 or central subfield thickness ≥250 μm received ranibizumab.
Outcomes | Time point | RAN 0.3mg | RAN 0.5mg | Sham (RAN after 6mo) |
---|---|---|---|---|
Mean BCVA change (letter) | 6 months | +16.6 | +18.3 | +7.3 |
12 months | +16.4 | +18.3 | +12.1 | |
Gained ≥15 letters in BCVA | 6 months | 55.2% | 61.1% | 28.8% |
12 months | 56.0% | 60.3% | 43.9% | |
BCVA ≥20/40 | 6 months | 67.9% | 64.9% | 41.7% |
Reduction in CFT | 6 months | 337um | 345um | 158um |
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