ABSTRACT NUMBER - 89

DEVELOPMENT OF MACULAR ATROPHY IN PATIENTS WITH NEOVASCULAR AGE- RELATED MACULAR DEGENERATION (NAMD) TREATED WITH RANIBIZUMAB OR AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN: PRIMARY RESULTS FROM THE RIVAL STUDY, A RANDOMIZED CLINICAL TRIAL


Mark C Gillies1, Alex P Hunyor1,2, Jennifer J Arnold3, Francois L Pecheur4, Ronelle-Mare Heath5, Robyn H Guymer6, Ian L McAllister7

Meeting:  2018 RANZCO


SESSION INFORMATION

Date:      -

Session Title: POSTER ABSTRACT- RETINA

Session Time:      -

Purpose: Compare the development of macular atrophy (MA) in patients receiving ranibizumab (RBZ) or aflibercept (AFL) using a Treat-and-Extend regimen for neovascular AMD.
Methods: RIVAL was a 24-month, partially masked, multicentre study that randomised 281 eyes (1:1) to 0.5 mg RBZ or 2.0 mg AFL arms. The pri- mary endpoint was the mean change in square- rooted area of MA at Month 24 (M24).
Results: 278 patients (141 RBZ; 137 AFL) were included in the analysis. 225 (80%) patients (117 [82%] RBZ; 108 [78%] AFL) completed the study. Baseline characteristics were comparable. From baseline to M24, the proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for RBZ and from 6% (8/137) to 32% (35/108) for AFL. The mean square-rooted area of MA SD increased from 0.02 0.10 mm (n = 140) to 0.40 0.73 mm (n = 114) and from 0.05 0.23 mm
(n = 137) to 0.35 0.65 mm (n = 106), respectively. The mean SD injections over 24 months was 17.7
6.4 for RBZ and 17.0 6.3 for AFL. With random effect mixed modelling, the mean (95% CI) change in square-rooted area of MA from baseline to M24

was 0.36 mm (0.27, 0.45) for RBZ and 0.28 mm (0.19, 0.37) for AFL (P = 0.24). Survival analysis of patients without MA at baseline found that respec- tively 27.5% (36/131) and 23.3% (30/129) of these patients in the RBZ and AFL arms developed MA within 24 months (HR [95% CI] = 1.08 [0.66,
1.77]; P = 0.75).
Conclusions: The RIVAL study found no significant difference between RBZ and AFL in the develop- ment of MA in nAMD patients with similar injec- tion loads.