A randomized, double masked, controlled study of efficacy and safety of intravitreal ranibizumab versus bevacizumab in subjects with macular edema secondary to branch retinal vein occlusion. BRANVO Study.

摘要

Purpose: To assess the efficacy and safety of intravitreal bevacizumab (BZB) compared to ranibizumab (RBZ) on best corrected visual acuity (BCVA) and reduction of central retinal thickness (CRT) in subjects with macular edema secondary to branch retinal vein occlusion (BRVO). Methods: This was a single center, non-inferiority trial (www.ctri.nic.in;REF/2012/01/003120) with equal allocation to groups. Seventy-five participants were randomized 1:1 using block randomization with a block size of 6 to receive either RZB or BZB. The primary outcome was the mean change in visual acuity (VA) at 6 months, with a non-inferiority limit of 5 letters. The other outcomes were mean change in central retinal thickness (CRT) and safety. At each visit the participants received BCVA using ETDRS protocol, slit lamp biomicroscopy, intra ocular pressure measurement, indirect ophthalmoscopy and optical coherence tomography. All participants received Intravitreal injection of the study drug at baseline and subsequently as per predefined criteria. Patients were evaluated monthly and macular laser was offered as per defined criteria after 3 months. Results: Participants were randomized to group A (RZB, n= 37) receiving and to group B (BZB, n=38). Mean age was 53 and 50 years in group A and B respectively. The mean BCVA at baseline was 52.81 ?± 14.41 letters in group A and 56.10 ?± 10.01 letters in group B. At end of 6 months the mean gain in VA was 18 letters (p0.0001; 95% Confidence Interval [CI], 12.78 to 22.60) in ranibizumab group and 15 letters (p0.0001; 95% CI, 12.00 to 20.50) in bevacizumab group. The comparison between RZB and BZB was non inferior (RZB minus BZB: 3 letters, p=0.74; 95% CI, -4.99 to 7.99). The mean CRT at baseline was 441.34 ?± 116.52??m in group A and 493.85 ?± 162.98??m in group B. At the end of 6 months the mean CRT was 265.53 ?± 100.56??m in RZB group and 276.71 ?± 67.79??m in BZB group. Conclusions: Ranibizumab and bevacizumab had equivalent effects on visual acuity in patients with macular edema due to BRVO. But there was a trend towards greater benefit in RZB group.