VIENNA — Ninety-six-week outcomes of the ALTAIR study demonstrated safety and efficacy of treat-and-extend aflibercept administration with both 2-week and 4-week adjustments in patients with wet AMD. The study involved 255 patients treated at 40 sites in Japan.
“Patients received three monthly doses of aflibercept and were then equally randomized in one of the two arms. In the first arm, the treatment interval was extended or shortened by 2 weeks. In the second arm, it was extended by 4 weeks or shortened by 2 or 4 weeks, depending on specific criteria,” Masahito Ohji, MD, PhD, said at the Euretina meeting.
One of the main interesting features of the study was the maintenance criteria, he said.
“For patients with no fluid, the interval was extended. For patients with new or persistent fluid, the interval was shortened, while for patients with residual but decreased fluid, the treatment interval was maintained,” he said.
A second interesting feature was that the minimum and maximum intervals were set at 8 weeks and 16 weeks, respectively, whereas in most previous studies, the minimum interval was 4 weeks and the maximum was 12 weeks, he said.
The positive 12-month results in terms of visual acuity gain and reduction of central retinal thickness, which have been previously presented, were substantially confirmed at week 96. These results were obtained with a mean number of 10.4 injections in both groups. One-third of the patients were treated with the minimum number of nine injections established by the study protocol.
The last treatment interval of 16 weeks or longer was achieved by 60% of the patients, while one-third of the patients had the last treatment interval of 8 weeks. The mean last interval was 12 weeks in both groups.
“The interval of 12 weeks or more at the last visit up to week 96 was achieved in approximately 60% of the patients in both groups, and the proportion of patients who extended to 16 weeks, and never shortened, was about 40%. On the other hand, approximately 25% of the patients stayed at 8 weeks with no extension,” Ohji said.
Safety data were consistent with previous studies. – by Michela Cimberle.
Reference: Ohji M et al. Two different treat-and-extend dosing regimens of intravitreal aflibercept in Japanese patients with wet age-related macular degeneration: 96 week results of the ALTAIR study. Presented at: Euretina; Sept. 20-23, 2018; Vienna.
Disclosure: Ohji reports receiving grants, consultancy fees, honoraria, and speaker’s fees from Bayer.