A prospective, randomized clinical trial compared two different treat-and-extend protocols with aflibercept in wet age-related macular degeneration (AMD).
A total of 52 treatment-naïve eyes (52 patients) with wet AMD underwent an induction phase of three monthly aflibercept injections, after which they were randomized 1:1 to one of the treat-and-extend protocols. The treat-and-extend protocol with moderate extensions (T&Em) extended the treatment interval one week at a time up to 12 weeks and then by two weeks up to 16 weeks. The treat-and-extended protocol with rapid extensions (T&Er) initially extended the treatment interval to eight weeks and then by two weeks up to 16 weeks. The primary outcome was the number of given aflibercept injections.
After two years, the mean visual gain from the baseline was 7.9 ± 14.5 letters in the T&Em group and 10.8 ± 16.5 letters in the T&Er group. The central subfield macular thickness decreased by a mean 203.0 ± 167.4 µm in the T&Em group and 192.3 ± 160.2 µm in the T&Er group. At the end of year two, the treatment interval was 10.3 ± 3.3 weeks in the T&Em group and 11.7 ± 3.5 in the T&Er group. Over two years, the total number of injections was 14.1 ± 3.1 in the T&Em group and 11.6 ± 2.0 in the T&Er group; during the second year, the total number of injections was 5.4 ± 1.8 in the T&Em group and 4.4 ± 1.4 in the T&Er group. In both groups, 71% of eyes had a dry macula at two years.
“At two years, the anatomical and functional responses between the two treatment groups were similar. However, the number of given aflibercept injections was smaller in the [T&Er] protocol,” the researchers summarized.