TY - JOUR
T1 - Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion
T2 - Results from the BRAVO and CRUISE trials
AU - Varma, Rohit
AU - Bressler, Neil M.
AU - Suñer, Ivan
AU - Lee, Paul
AU - Dolan, Chantal M.
AU - Ward, James
AU - Colman, Shoshana
AU - Rubio, Roman G.
N1 - Funding Information:
Neil M. Bressler: Principal investigator of grants at The Johns Hopkins University sponsored by (not including the National Institutes of Health) - 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.; The EMMES Corporation. (Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the School of Medicine, which receives the grants, through the Office of Research Administration. Individual investigators who participate in sponsored projects are not compensated directly by the sponsor, but may receive salary or other support from the institution to support their effort on the projects.)
PY - 2012/10
Y1 - 2012/10
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ophtha.2012.05.017
DO - 10.1016/j.ophtha.2012.05.017
M3 - Article
C2 - 22817833
AN - SCOPUS:84867100215
VL - 119
SP - 2108
EP - 2118
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 10
ER -