Abstract | PURPOSE: DESIGN: Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. PARTICIPANTS: METHODS: MAIN OUTCOME MEASURES: The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT). RESULTS: Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P<0.0001 for each ranibizumab group vs sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 microm in the sham group (P<0.0001 for each ranibizumab group vs sham). The median percent reduction in excess foveal thickness at month 6 was 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO. CONCLUSIONS:
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Authors | Peter A Campochiaro, Jeffrey S Heier, Leonard Feiner, Sarah Gray, Namrata Saroj, Amy Chen Rundle, Wendy Yee Murahashi, Roman G Rubio, BRAVO Investigators |
Journal | Ophthalmology
(Ophthalmology)
Vol. 117
Issue 6
Pg. 1102-1112.e1
(Jun 2010)
ISSN: 1549-4713 [Electronic] United States |
PMID | 20398941
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Vascular Endothelial Growth Factor A
- Ranibizumab
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage)
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Double-Blind Method
- Endpoint Determination
- Female
- Humans
- Injections
- Laser Coagulation
- Macular Edema
(drug therapy, etiology, physiopathology)
- Male
- Middle Aged
- Prospective Studies
- Ranibizumab
- Retinal Vein Occlusion
(complications)
- Treatment Outcome
- Vascular Endothelial Growth Factor A
(antagonists & inhibitors)
- Visual Acuity
(physiology)
- Vitreous Body
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