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C. D. Regillo, R. Rubio, N. Saroj, Z. Li, A. Rundle, S. Gray, W. Yee Murahashi; Subgroup Analyses of Visual Acuity Outcomes in the CRUISE Study of Intravitreal Ranibizumab in Patients with Macular Edema Following Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3566.
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Subgroup analyses of efficacy outcomes for patients with macular edema (ME) following central retinal vein occlusion (CRVO) who participated in CRUISE.
Phase III, double-masked, controlled study of 392 patients with ME (central subfield thickness ≥250 µm) following CRVO randomized to receive 6 monthly intravitreal injections of 0.3 mg (n=132) or 0.5 mg (n=130) ranibizumab or sham injections (n=130) 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 0.8 (16.2), 12.7 (15.9), and 14.9 (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, change in BCVA was greater for those with worse baseline BCVA and baseline CFT ≥450 µm (Table).
Ranibizumab provided visual benefit to patients with ME following CRVO. Patients with the worst BCVA and greatest CFT at baseline tended to derive the most benefit.
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