Alex P Hunyor1,2, Jennifer J Arnold3, Ian L McAllister4, Francois L Pecheur5, Ronelle-Mare Heath6, Robyn H Guymer7, Marc C Gillies2
Purpose: report 24-month secondary efﬁcacy out- comes of RIVAL, a study designed to investigate the development of macular atrophy in nAMD patients receiving ranibizumab (RBZ) or aﬂibercept (AFL).
Methods: 24-month multicentre phase IV study that randomized 281 patients (1:1) to receive 0.5mg RBZ or 2.0mg AFL following a Treat-and-Extend regi- men. Best-Corrected Visual Acuity (BCVA) assessors and the reading center were masked.
Results: The analysis included 278 patients (141 RBZ; 137 AFL). 225 (80%) patients (117 [82%]
RBZ; 108 [78%] AFL) completed the study. Demo- graphic and baseline characteristics were similar. The mean SD number of injections over 24 months was 17.7 6.4 for RBZ and 17.0 6.3 for AFL. From baseline to Month 24 (M24), the mean SD BCVA increased from 65.3 15.1 letters (n = 141) to 72.5 16.4 letters (n = 117) for RBZ, and from
65.1 12.5 letters (n = 137) to 70.3 14.9 letters (n = 108) for AFL, while the mean Central Subﬁeld Foveal Thickness (CSFT) decreased from 468 151 μm (n = 141) to 306 81 μm (n = 117), and from 484 168 μm (n = 137) to 299 78μm (n = 108), respectively. Random effect mixed modelling found the mean (95% CI) changes in BCVA and in CSFT from baseline to M24 were +6.6 letters (4.7, 8.5) and −161 μm (−174, −147) for RBZ, compared to +4.6 letters (2.7, 6.6) and −173 μm (−186, −159) for AFL; the respective treatment effects (95%CI) were 2.0 letters (−0.7, 4.6) (P = 0.15) and 12 μm (−7, 31) (P = 0.23).
Conclusions: Ranibizumab and aﬂibercept achieved similar number of injections, visual acuity and reti- nal thickness improvements over 24 months using a Treat-and-Extend regimen for nAMD.
COMPARISON OF RANIBIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATED FOLLOWING A ?TREAT AND EXTEND? PROTOCOL: EFFICACY VARIABLES FROM THE PRE-SPECIFIED 12- MONTH INTERIM ANALYSIS OF THE RIVAL STUDY