Comparison of two different treat-and-extend protocols with aflibercept in wet age-related macular degeneration

Abstract

Purpose: To optimize the aflibercept treat-and-extend protocol in wet age-related macular degeneration (wAMD). Methods: A prospective randomized clinical trial consisting of 52 eyes from 52 patients with treatment-naïve wAMD. Patients received three monthly aflibercept injections and were then randomized 1:1 to two different dosing protocols. In treat-and-extend protocol with moderate extensions (T&Em), after the loading phase the treatment interval was extended 1 week at a time up to 12 weeks and then by 2 weeks up to 16 weeks. In treat-and-extend protocol with rapid extensions (T&Er), the interval was first extended to 8 weeks and then by 2 weeks at a time up to 16 weeks. Main outcome measure was the number of given aflibercept injections. Results: Fifty (96%) patients completed the 1-year follow-up. Patient and ophthalmic baseline variables were comparable between the study groups. At 1 year, central subfield macular thickness reduced by 194.3 ± 153.6 μm in T&Em protocol, compared with 194.2 ± 176.6 μm in T&Er (p = 0.997). Eyes with T&Em gained 10.3 ± 11.5 letters from baseline and eyes with T&Er 11.4 ± 10.6 letters (p = 0.434), and dry macula was observed in 72% of eyes with T&Em compared to 68% with T&Er (p = 0.758). At 1 year, the treatment interval was 8.5 ± 2.2 weeks in T&Em and 10.3 ± 2.8 weeks in T&Er (p = 0.017), and the total number of injections 8.64 ± 1.58 and 6.96 ± 0.79, respectively (p < 0.001). In the rapid extensions protocol, 48% of eyes reached a 12-week treatment interval or beyond at 1 year. Conclusions: At one year, the anatomical and functional responses were comparable between the moderate and rapid extensions protocols, with fewer aflibercept injections in the rapid extension protocol.