title: Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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: Doheny Eye Institute, University of Southern California, Los Angeles, California, USA. rvarma@usc.edu
authors: Rohit
authors: R
authors: Varma
authors: Neil M
authors: NM
authors: Bressler
authors: Ivan
authors: I
authors: Suñer
authors: Paul
authors: P
authors: Lee
authors: Chantal M
authors: CM
authors: Dolan
authors: James
authors: J
authors: Ward
authors: Shoshana
authors: S
authors: Colman
authors: Roman G
authors: RG
authors: Rubio
mesh_terms: D000203:Activities of Daily Living; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D000069579:Ranibizumab; D012170:Retinal Vein Occlusion / Q000188:drug therapy* / Q000503:physiopathology; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab