Abstract
Purpose: :
To evaluate in patients with macular edema (ME) following branch retinal vein occlusion (BRVO) the effects of ranibizumab on central foveal thickness (CFT) and macular volume (MV) and assess the relationship between visual and anatomical outcomes.
Methods: :
Phase III, double-masked, controlled study. Patients with ME (central subfield thickness ≥250 µm) following BRVO were 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. Zeiss Stratus optical coherence tomography (OCT) images at Days 0 and 7 and Months 1, 2, 3, and 6 were evaluated. Primary efficacy outcome was mean change from baseline best-corrected visual acuity (BCVA) at Month 6. Prespecified secondary endpoints included change from baseline CFT over time and proportion of patients with CFT ≤250 µm at Month 6. We also evaluated change from baseline MV and the correlation between changes in CFT and BCVA (post hoc analyses) at Month 6.
Results: :
At Day 7, compared with the sham group, the 0.3 mg and 0.5 mg ranibizumab groups had a greater change in mean [SD] CFT (5.7 [95.4] µm vs. -264.1 [182.8] µm and -263.9 [198.3], p<0.0001) and MV (0.01 [0.40] µm vs. -1.05 [1.24] µm and -1.07 [1.54] µm, p<0.0001). The early benefit was sustained at Month 6 (CFT: -157.7 [224.2] µm vs. -337.3 [224.4] µm and -345.2 [238.2] µm, p<0.0001; MV: -1.03 [1.57] µm vs. -2.28 [1.74] µm and -2.64 [2.03] µm, p<0.0001). At Month 6, the proportion of patients with CFT ≤250 µm in the sham, 0.3 mg, and 0.5 mg groups was 45.5%, 91.0%, and 84.7% (p<0.0001). (All p values are for each ranibizumab group vs. sham.) Change from baseline BCVA and CFT at Month 6 had a moderate negative correlation, with Pearson correlations of -0.23, -0.21, and -0.29 in the sham, 0.3 mg, and 0.5 mg groups.
Conclusions: :
Monthly ranibizumab provided a significant reduction in ME in patients with BRVO. Anatomical benefits were observed as early as Day 7 and sustained at Month 6.
Clinical Trial: :
www.clinicaltrials.gov NCTOO486
Keywords: retina • vascular occlusion/vascular occlusive disease • vascular endothelial growth factor