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A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)
October 1, 2011
Clinical trial
Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study.
Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG.
Main finding: Treatment with ranibizumab as needed during months 6 through 11 maintained the visual and anatomic benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after CRVO, with low rates of ocular and nonocular safety events.
- Purpose: To assess the efficacy and safety of intravitreal ranibizumab in patients with macular edema after central retinal vein occlusion
- Study type: Randomized controlled trial.
- Condition: Central retinal vein occlusion
Participants: ≥18 yo with centre-involving macular oedema secondary to BRVO, BCVA 20/40-20/320, mean central subfield thickness ≥250 μm
- n=392
Intervention:
Group 1: Intravitreal Ranibizumab 0.3mg
Group 2: Intravitreal Ranibizumab 0.5mg
Group 3: Sham
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 | 12.7 | 14.9 | 0.8 |
| 12 months | 13.9 | 13.9 | 7.3 | |
| Gained ≥15 letters in BCVA | 6 months | 46.2% | 47.7% | 16.9% |
| 12 months | 47.0% | 50.8% | 33.1% | |
| BCVA ≥20/40 | 6 months | 43.9% | 46.9% | 20.8% |
| Reduction in CFT | 6 months | 434um | 452um | 168um |
June 1, 2010
Clinical trial
Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study.
Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY.
Main finding: Ranibizumab is an effective treatment for macular edema after CRVO
- Purpose: To assess the efficacy and safety of intravitreal ranibizumab in patients with macular edema after central retinal vein occlusion
- Study type: Randomized controlled trial.
- Condition: Central retinal vein occlusion
Participants: ≥18 yo with centre-involving macular oedema secondary to BRVO, BCVA 20/40-20/320, mean central subfield thickness ≥250 μm
- n=392
Intervention:
Group 1: Intravitreal Ranibizumab 0.3mg
Group 2: Intravitreal Ranibizumab 0.5mg
Group 3: Sham
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 | 12.7 | 14.9 | 0.8 |
| 12 months | 13.9 | 13.9 | 13.9 | |
| Gained ≥15 letters in BCVA | 6 months | 46.2% | 47.7% | 16.9% |
| 12 months | 47.0% | 50.8% | 33.1% | |
| BCVA ≥20/40 | 6 months | 43.9% | 46.9% | 20.8% |
| Reduction in CFT | 6 months | 434um | 452um | 168um |
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