Anti-VEGF comparison

Ranibizumab and aflibercept both effective in RIVAL study for nAMD

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Both ranibizumab (Lucentis, Novartis) and aflibercept (Eylea, Regeneron) are effective treatments for neovascular age-related macular degeneration (nAMD) when used in a treat-and-extend protocol, according to the interim 12-month results of the RIVAL study presented at the 17th EURETINA Congress in Barcelona. “This is the first randomised controlled trial to compare ranibizumab and aflibercept in nAMD patients using an identical treat-and-extend dosing regimen. Significant visual acuity improvements were achieved by patients in both treatment arms and with the same mean number of injections,” said Mark Gillies MB, BS, PhD, FRANZCO, Director of Research, Save Sight Institute, and Director of the Macula Research Group at the University of Sydney, principal investigator of the RIVAL study. The primary outcome of the RIVAL study is the development of geographic atrophy (GA) over a two-year period, said Prof Gillies. It follows the results of the Fight Retinal Blindness (FRB) Study Group’s report of a lower rate of GA compared to the SEVEN-Up study, which looked at seven-year outcomes in ranibizumab-treated patients that had participated in the ANCHOR, MARINA and HORIZON trials. “The SEVEN-UP study followed 65 patients who had been through these trials and they reported that macular atrophy was affecting the centre of the fovea in nearly 90% of cases, suggesting that this would eventually happen to practically all patients on chronic VEGF inhibition. In our FRB study we followed a cohort of 120 eyes for seven years and found that geographic atrophy was the cause of a 10- or greater letter loss in only around 40% of eyes,” he said. Atrophy progression may be associated with loss of vision over time, said Prof Gillies. The mean visual acuity decline from baseline was -8.6 letters for SEVEN-UP compared to -2.6 letters for the FRB study, with 40% of FRB eyes achieving 20/40 or better, compared to 23% in SEVEN-UP. “The big difference between the studies was that we were treating much more intensively in Australia, with two or three times as many injections as patients received in the final three years of SEVEN-UP,” he said. Prof Gillies presented the 12-month data for 141 patients who received ranibizumab and 139 patients treated with aflibercept. Three markers of disease activity were used during the treat-and-extend period: a loss of visual acuity of more than five letters compared to the best visual acuity recorded since treatment began; new retinal haemorrhage; and the presence of any intraretinal fluid or subretinal fluid on OCT. “If one marker was present the injection interval was reduced by two weeks, and if two or more criteria were present, the interval was back to four weekly injections,” said Prof Gillies. Similar visual acuity improvements were achieved by month 12 in both treatment arms, with the same mean number of injections. Prof Gillies said that the study was ongoing, and a full analysis would be carried out at the end of the 24-month follow-up period. Mark Gillies: mark.gillies@sydney.edu.au
Tags: anti-VEGF drugs, neovascular age-related macular degeneration