Comparison of Two Different Treat-and-Extend Protocols with Aflibercept in Wet Age-Related Macular Degeneration: Two-Year Results.

Introduction: To optimize the aflibercept treat-and-extend protocol in wet age-related macular degeneration (wAMD) beyond the 1-year interim report.

Methods: This 2-year prospective randomized clinical trial included 52 eyes from 52 patients with treatment-naïve wAMD. After the induction phase of three monthly aflibercept injections, patients were randomized 1:1 to two different treat-and-extend protocols. In the treat-and-extend protocol with moderate extensions (T&Em), the treatment interval was extended 1 week at a time up to 12 weeks, and then by 2 weeks up to 16 weeks. In the treat-and-extend protocol with rapid extensions (T&Er), the treatment interval was initially extended to 8 weeks, and then by 2 weeks up to 16 weeks. Main outcome measure was the number of given aflibercept injections.

Results: At the study end point at 2 years, the mean visual gain from the baseline was 7.9 ± 14.5 letters in T&Em, compared to 10.8 ± 16.5 letters in T&Er protocol (P = 0.726). The mean decrease in central subfield macular thickness was 203.0 ± 167.4 µm in T&Em and 192.3 ± 160.2 µm in T&Er protocol (P = 0.822). Treatment interval was 10.3 ± 3.3 weeks in T&Em and 11.7 ± 3.5 in T&Er protocol (P = 0.164) at the end of year 2. The total number of injections in 2 years was 14.1 ± 3.1 in T&Em and 11.6 ± 2.0 in T&Er (P = 0.002), and the number of injections during the second year was 5.4 ± 1.8 and 4.4 ± 1.4, respectively (P = 0.043). A total of 71% of the eyes in both treatment groups had a dry macula at the study end point.

Conclusions: At 2 years, the anatomical and functional responses between the two treatment groups were similar. However, the number of given aflibercept injections was smaller in the rapid extensions protocol.

Trial Registration: EU Clinical Trials Register Number, 2015-001394-41/FI.