Mark C. Gillies, Alex P. Hunyor, Jennifer J. Arnold, Francois Pecheur, Kathryn Underhill, Robyn H. Guymer, Ian L. McAllister
Purpose: To report results of the pre-specifted 12- month interim analysis of key secondary endpoints from the RIVAL study: number of injections and change in Best Corrected Visual Acuity (BCVA) from baseline at Month 12. The study primary endpoint will compare the rate of development of Geographic Atrophy at 24 months in neovascular Age-Related Macular Degeneration (nAMD) patients treated with
0.5 mg ranibizumab (RBZ) and 2.0 mg a?ibercept (AFL) using a ?Treat and Extend? regimen (T&E). Methods: RIVAL is a 24-month, randomised, par- tially masked, multi-centre Phase IV study. 281 eyes were randomised 1:1 to RBZ or AFL arms. Follow- ing three initial monthly injections, patients entered the T&E phase.
Results: 278 patients (n=141 RBZ; n=137 AFL) were included in the interim analysis. Demo- graphics and baseline characteristics were compara- ble between the two arms. The mean BCVA at Baseline was 65.3 letters (RBZ) vs. 65.1 letters (AFL). At Month 12, the mean BCVA for completers was 72.9 letters for RBZ (n=127) and 70.5 letters for AFL (n=121). When applying a random effects mixed model, the change from baseline at Month 12 was assessed to be +6.93 (95% CI: 5.20-8.65) for
RBZ and +4.41 (95% CI: 2.64-6.18) for AFL. The
mean number of injections over 12 months was 9.7 injections in both arms.
Conclusions: This pre-planned interim analysis of key secondary endpoints from the RIVAL study showed that signiftcant visual improvements were achieved at 12 months with both ranibizumab and a?ibercept in nAMD patients, with similar number of injections when using a T&E regimen.