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

Publication ,  Journal Article
Varma, R; Bressler, NM; Suñer, I; Lee, P; Dolan, CM; Ward, J; Colman, S; Rubio, RG; BRAVO and CRUISE Study Groups,
Published in: Ophthalmology
October 2012

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.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

October 2012

Volume

119

Issue

10

Start / End Page

2108 / 2118

Location

United States

Related Subject Headings

  • Visual Acuity
  • Treatment Outcome
  • Surveys and Questionnaires
  • Sickness Impact Profile
  • Retinal Vein Occlusion
  • Ranibizumab
  • Ophthalmology & Optometry
  • Macular Edema
  • Intravitreal Injections
  • Humans
 

Citation

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Varma, R., Bressler, N. M., Suñer, I., Lee, P., Dolan, C. M., Ward, J., … BRAVO and CRUISE Study Groups, . (2012). Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials. Ophthalmology, 119(10), 2108–2118. https://doi.org/10.1016/j.ophtha.2012.05.017
Varma, Rohit, Neil M. Bressler, Ivan Suñer, Paul Lee, Chantal M. Dolan, James Ward, Shoshana Colman, Roman G. Rubio, and Roman G. BRAVO and CRUISE Study Groups. “Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.Ophthalmology 119, no. 10 (October 2012): 2108–18. https://doi.org/10.1016/j.ophtha.2012.05.017.
Varma R, Bressler NM, Suñer I, Lee P, Dolan CM, Ward J, et al. Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials. Ophthalmology. 2012 Oct;119(10):2108–18.
Varma, Rohit, et al. “Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.Ophthalmology, vol. 119, no. 10, Oct. 2012, pp. 2108–18. Pubmed, doi:10.1016/j.ophtha.2012.05.017.
Varma R, Bressler NM, Suñer I, Lee P, Dolan CM, Ward J, Colman S, Rubio RG, BRAVO and CRUISE Study Groups. Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials. Ophthalmology. 2012 Oct;119(10):2108–2118.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

October 2012

Volume

119

Issue

10

Start / End Page

2108 / 2118

Location

United States

Related Subject Headings

  • Visual Acuity
  • Treatment Outcome
  • Surveys and Questionnaires
  • Sickness Impact Profile
  • Retinal Vein Occlusion
  • Ranibizumab
  • Ophthalmology & Optometry
  • Macular Edema
  • Intravitreal Injections
  • Humans