Clinical researchers in Sydney state that neither ranibizumab nor aflibercept for nAMD are superior to the other regarding the average visual acuity gains and number of injections during 1 year in a treat-and-extend regimen. The researchers indicate that the clinical trial results provided a 12-month interim analysis of two predefined secondary efficacy end-points and may now assess to evaluate 24-month studies in due course. According to the Principal Investigator, Dr. Mark Gillies, the study could not uncover any “significant differences in the outcomes of eyes treated with aflibercept or ranibizumab for neovascular (wet) age-related macular degeneration. They received the same number of injections on average using the treatment regimen that is most commonly used in real-world practice, ‘treat and extend’ with similar improvements in vision. Both drugs give excellent results for this condition if they are given adequately”.
The clincial trial study was termed by the acroynm, entitled “RIVAL” – the Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients. The study was conducted in 24 sites in Australia and included 281 treatment-naive eyes from 281 participants with active choroidal neovascularization secondary to nAMD and a visual acuity letter score of 23 or greater who were recruited between April, 2014, and October 31, 2015. The participants were randomized in a ratio of 1:1 to receive intravitreal injections of 0.5mg of ranibizumab or 2.0mg of aflibercept. Following receiving three initial monthly injections, the participants were then used in a treat-and-extend regimen.
According to the study results, 281 participants, 148 (52.7%) were women and the mean (SD) age was 77.7 (8.1) years. The baseline mean BCVA letter score (approximate Snellen equivalent) was 65.3 (20/50) in the ranibizumab arm and 65.1 (20/50) in the aflibercept arm. One hundred twenty-seven ranibizumab participants (90.1%) and 121 aflibercept participants (88.3%) completed month 12 with a mean (SD [Snellen equivalent]) BCVA letter score of 72.9 (15.5 [20/32]) and 70.5 (14.6 [20/40]), respectively. The mean change in BCVA letter scores from baseline to month 12 was 7.2 (95%CI, 5.5-8.9) for ranibizumab and 4.9 (95%CI, 3.1-6.6) for aflibercept (letter score difference, 2.3; 95%CI, −0.1 to 4.7; P= .06). The mean number of injections from baseline to month 12 was 9.7 in both the ranibizumab (SD, 2.8) and aflibercept (SD, 2.6) arms with a rate ratio of 1.00 (95%CI, 1.0-1.1; P= .86). In a discussion and conclusion of the trial results, the research team stated that, “[t]he main finding from this preplanned interim analysis of the RIVAL study is that visual acuity gains at 12 months were not substantially different between ranibizumab and aflibercept for nAMD when using an identical TE regimen, with both agents requiring the same mean number of injections during the first 12 months of the study. Further follow-up to 2 years may determine if advantages of one over the other can be identified.”