Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup
Annabelle A. Okada, Kanji Takahashi, Masahito Ohji, SungChul Charles Moon, Tobias Machewitz, Koji Sasaki, The ALTAIR Study Investigators, Masahito Ohji, Tsukasa Hanemoto, T. Kaga, Takeya Kouno, Hirokuni Kitamei, Shinpei Sato, Kanji Takahashi, Ryoji Yanai, Eiichi Uchio, Kazunori Miyata, Yoshihiro Wakabayashi, Takatoshi Maeno, Tsutomu Yasukawa, Masayuki Horiguchi, Tetsuya Nishimura, Akiteru Kawahara, Yasuo Kurimoto, K Murai, Namie Kobayashi, Wataru Kimura, Eriko Matsushita, Tomohiro Iida, Kanako Yasuda, Masahiro Miura, Annabelle A. Okada, Ryusaburo Mori, Atsushi Sugiyama, Yasuo Ito, Daisaku Kimura, Kei Nakai, Chota Matsumoto, Shinobu Takeuchi, Kishiko Okoshi, Yoshihisa Nuno, Yohei Nomoto, Toshio Mori, Muneyasu Takeda, Noriko Yoshida, Mio Hosokawa, Kohei Sonoda
Abstract
INTRODUCTION: To explore the efficacy and safety of intravitreal aflibercept (IVT-AFL) proactive, individualized treat-and-extend (T&E) regimens in exudative age-related macular degeneration (AMD) in the subgroup of patients with polypoidal choroidal vasculopathy (PCV) enrolled in the ALTAIR study. METHODS: This was a PCV subgroup analysis of ALTAIR, a 96-week, randomized, open-label, phase 4 study in treatment-naïve patients with exudative AMD in Japan. Following three initial monthly doses, patients received IVT-AFL at week 16 and were randomized 1:1 to T&E regimens with either 2-week (IVT-AFL-2W) or 4-week (IVT-AFL-4W) adjustments. The primary endpoint of ALTAIR was the mean change in best-corrected visual acuity (BCVA) from baseline to week 52. Endpoints were assessed at weeks 52 and 96. Safety analyses were conducted. RESULTS: A total of 90 patients with PCV were included within the full analysis set. From baseline to week 52, mean [standard deviation (SD)] change in BCVA was + 7.5 (14.7) letters and + 8.2 (11.6) letters in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 96, 91.3% and 90.9% of patients maintained vision in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 52, mean (SD) change in central retinal thickness was - 153 (177) µm and -112 (122) µm in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. Overall, 51.1% of patients (IVT-AFL-2W, 43.5%; IVT-AFL-4W, 59.1%) achieved a treatment interval of 16 weeks between weeks 16 and 96. The safety profile of IVT-AFL was consistent with previous studies. CONCLUSION: In treatment-naïve patients with PCV, IVT-AFL administered using two different T&E regimens improved and maintained functional and anatomic outcomes over 96 weeks while minimizing treatment burden. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02305238.