Purpose:
Subgroup analyses of visual acuity outcomes for patients with macular edema (ME) following branch retinal vein occlusion (BRVO) who participated in BRAVO.
Methods:
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.
Results:
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).
Conclusions:
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.
Clinical Trial:
www.clinicaltrials.gov NCT00486018
Keywords: vascular occlusion/vascular occlusive disease • edema • vascular endothelial growth factor