Improved Vision-Related Function after Ranibizumab for Macular Edema after Retinal Vein Occlusion

• Published in: Ophthalmology (Rochester, Minn.) Vol. 119; no. 10; pp. 2108 - 2118
• Main Authors: Varma, Rohit, MD, Bressler, Neil M., MD, Suñer, Ivan, MD, Lee, Paul, MD, Dolan, Chantal M., PhD, Ward, James, PhD, Colman, Shoshana, PhD, Rubio, Roman G., MD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.10.2012
• Subjects: Ophthalmology
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2012.05.017

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 Ranibizuma B for the Treatment of Macular Edema following B RA nch Retinal V ein O cclusion: Evaluation of Efficacy and Safety (BRAVO) trial or the C entral R etinal Vein Occl U s I on S tudy: E valuation 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.