Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.

Abstract

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.

• Authors: Rohit Varma, Neil M Bressler, Ivan Suñer, Paul Lee, Chantal M Dolan, James Ward, Shoshana Colman, Roman G Rubio, BRAVO and CRUISE Study Groups
• Journal: Ophthalmology (Ophthalmology) Vol. 119 Issue 10 Pg. 2108-18 (Oct 2012) ISSN: 1549-4713 [Electronic] United States
• PMID: 22817833 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• Ranibizumab

Topics

• Activities of Daily Living
• Angiogenesis Inhibitors (administration & dosage)
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Double-Blind Method
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Macular Edema (drug therapy, physiopathology)
• Ranibizumab
• Retinal Vein Occlusion (drug therapy, physiopathology)
• Sickness Impact Profile
• Surveys and Questionnaires
• Treatment Outcome
• Visual Acuity (physiology)