Session Title: Quick Fire Free Paper 1
Session Date/Time: Thursday 11/09/2014 | 08:00-10:00
Paper Time: 08:35
Venue: Boulevard D
First Author: : L.O.Hattenbach GERMANY
Co Author(s): : N. Eter H. Hans N. Feltgen L. Gabriele G. Lambrou T. Knorr
The COMRADE-B study was a phase IIIb, prospective, double-masked, randomized trial designed to evaluate the efficacy and safety of 0.5 mg ranibizumab compared with 0.7 mg dexamethasone in BRVO. An exploratory objective of this study was to compare the development of retinal ischemia under treatment with ranibizumab or Ozurdex® , both administered as per label, over 6 months
Analysis of a multicenter randomized clinical trial (COMRADE-B)
Patients with visual impairment due to macular edema following BRVO (n = 244) were randomized 1:1 to receive 0.5 mg ranibizumab intravitreal injections (RAN) on an as-needed basis (PRN) after three loading doses or to receive an intravitreal implant containing dexamethasone 0.7 mg (DEX) every 6 month. Best-corrected mean average visual acuity (BCVA) change over 6 month (primary endpoint), changes of BCVA and retinal thickness, QoL parameters and occurrence of AEs were evaluated. The presence of Central (Cen) and peripheral (Per) retinal ischemia at Baseline and Month 6 was the subject of an exploratory analysis aiming to investigate the resolution of ischemia as well as the development of new ischemic cases by month 6 under treatment with either RAN or DEX.
BCVA at baseline was 57.2 ± 11.9 (SD) and 58.1 ± 12.0 letters for the RAN and DEX group respectively. The mean average change over 6 month was + 14.92 ± 9.86 letters (RAN) and + 10.12 ± 9.51 letters (DEX) (p <0.0001). The mean change at month 6 was 17.3 ± 11.8 (RAN) vs. 9.2 ± 12.5 (DEX) letters. CRT was reduced from baseline values (545 ± 224 for RAN; 541 ± 233 for DEX) by -275 ± 210 (RAN) and -130 ± 211 (DEX) at 6 month (p<0.001). QoL improvement from baseline to month 6 was significantly higher with RAN than with DEX (7.1±10.1 vs. 2.8±12.4; p=0.003). No significant safety differences were noted except for the more frequent IOP increase seen with DEX (odds ratio CI for a ≥10% increase: 0.095-0.382 p<0.0001). Central/peripheral retinal ischemia resolved under treatment in 17(14%)/10(8%) of RAN and in 12(11%)/4(4%) DEX patients. New cases of cen/per retinal ischemia developed in 9(7%)/14(12%) of RAN and in 16(14%)/23(21%) of DEX patients. The odds ratio for deterioration of Cen/Per ischemic status was 0.605 (p=0.11) / 0.478 (p=0.024), favoring Ranibizumab.
In BRVO patients, ranibizumab 0.5mg PRN resulted in significantly higher BCVA gains compared to intravitreal dexamethasone implant. Both treatments were different in respect to ischemic progression of the retina. Ranibizumab had seems to have a positive effect on improvement of ischemic status compared to Dexamethasone implant.