Journal
OPHTHALMOLOGY
Volume 119, Issue 10, Pages 2108-2118Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.ophtha.2012.05.017
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Funding
- Allergan
- Genentech
- Optovue
- Pfizer
- Abbott Medical Optics, Inc.
- Alimera Sciences
- Allergan USA, Inc.
- Bausch & Lomb Incorporated
- Carl Zeiss Meditec, Inc.
- DIAGNOS Inc.
- ForSight Labs, LLC
- Genentech, Inc
- Genzyme Corporation
- Lumenis, Inc
- Notal Vision
- Novartis Pharma AG
- Ora, Inc
- Pfizer, Inc
- Quark Biotech, Inc
- Regeneron Pharmaceuticals, Inc
- Research to Prevent Blindness, Inc
- Steba Biotech S.A.
- EMMES Corporation
- Office of Research Administration
- Alcon
- National Institutes of Health
- IH
- Genentech, Inc, South San Francisco, California
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Purpose: To examine the impact of intravitreal ranibizumab on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) through 6 months in patients with macular edema (ME) secondary to branch or central retinal vein occlusion (RVO). Design: Two multicenter, double-masked trials, which enrolled participants with ME secondary to branch or central RVO: the RanibizumaB for the Treatment of Macular Edema following BRAnch Retinal Vein Occlusion: Evaluation of Efficacy and Safety (BRAVO) trial or the Central Retinal Vein OcclUsIon Study: Evaluation of Efficacy and Safety (CRUISE) trial. Participants: Three hundred ninety-seven BRAVO and 392 CRUISE patients. Methods: Patients were randomized 1: 1: 1 to monthly sham, 0.3-mg, or 0.5-mg injections of ranibizumab for 6 months. Main Outcome Measures: Although visual acuity was the main outcome measure for the trials, mean change from baseline in NEI VFQ-25 scores at month 6 was a secondary outcome measure. Results: In BRAVO, among the 132, 134, and 131 patients randomized, respectively, to sham, 0.3 mg ranibizumab, or 0.5 mg ranibizumab, the study eye was the worse-seeing eye in 121 (91.7%), 118 (88.1%), and 125 (95.4%) patients and 123 (93.2%), 128 (95.5%), and 125 (95.4%), respectively, had a 6-month follow-up visit. In CRUISE, among the 130, 132, and 130 patients randomized, respectively, to sham, 0.3 mg ranibizumab, and 0.5 mg ranibizumab, the study eye was the worse-seeing eye in 117 (90.0%), 123 (93.2%), and 120 (92.3%) patients and 115 (88.5%), 129 (97.7%), and 119 (91.5%), respectively, had a 6-month follow-up visit. In both trials, patients treated with ranibizumab reported greater mean improvements in visual function, with substantial differences observed as early as month 1, including the NEI VFQ-25 composite score and near and distance activities subscales, compared with sham patients. P values for comparisons with sham for the composite score and these 2 subscales were <0.05. Conclusions: These results from the BRAVO and CRUISE trials indicate that patients with ME from RVOs treated with monthly ranibizumab report greater improvements in vision-related function compared with sham-treated patients through 6 months, even when a majority of patients present with RVOs in the worse-seeing eye. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2012; 119:2108-2118 (C) 2012 by the American Academy of Ophthalmology.
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