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M. Singer, S. Gray, W. Yee Murahashi, N. Saroj, A. Rundle, R. Rubio; Subgroup Analyses of Visual Acuity Outcomes in the BRAVO Study of Intravitreal Ranibizumab in Patients With Macular Edema Following Branch Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3561.
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© ARVO (1962-2015); The Authors (2016-present)
Subgroup analyses of visual acuity outcomes for patients with macular edema (ME) following branch retinal vein occlusion (BRVO) who participated in BRAVO.
Phase III, double-masked, controlled study of 397 patients with ME (central subfield thickness ≥250 µm) following BRVO randomized to receive 6 monthly intravitreal injections of 0.3 mg (n=134) or 0.5 mg (n=131) ranibizumab or sham injections (n=132) followed by 6 months of observation, during which all patients could receive ranibizumab PRN if prespecified criteria were met. Primary efficacy endpoint was mean change from baseline best-corrected visual acuity (BCVA) at Month 6. Prespecified subgroup analyses included change from BCVA according to baseline BCVA (≤34, 35-54, or ≥55 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and baseline optical coherence tomography (OCT)-assessed central foveal thickness (CFT; <450 µm, ≥450 µm). Post hoc analysis of BCVA outcomes according to time from diagnosis to screening (<3 months, ≥3 months) was also performed.
At Month 6, patients in the sham, 0.3 mg, and 0.5 mg groups had gained a mean (SD) of 7.3 (13.0), 16.6 (11.0), and 18.3 (13.2) letters from baseline (p<0.0001 each ranibizumab group vs. sham). The treatment group differences in BCVA outcomes were maintained when analyzed by subgroup. For ranibizumab-treated patients the mean change in BCVA was greater for those with worse BCVA and CFT ≥450 µm at baseline and <3 months from diagnosis to screening (Table).
Ranibizumab provided visual benefit to patients with ME following BRVO. Patients with the worst BCVA and greatest CFT at baseline tended to derive the most benefit.
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