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, ALTAIR Study Investigators, Masahito Ohji, Tsukasa Hanemoto, Tatsushi 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, Kenichi Murai, Namie Kobayashi, Wataru Kimura, Eriko Matsushita, Tomohiro Iida, Kanako Yasuda, Masahiro Miura, Annabelle Ayame 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, Annabelle A Okada, Kanji Takahashi, Masahito Ohji, SungChul Charles Moon, Tobias Machewitz, Koji Sasaki, ALTAIR Study Investigators, Masahito Ohji, Tsukasa Hanemoto, Tatsushi 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, Kenichi Murai, Namie Kobayashi, Wataru Kimura, Eriko Matsushita, Tomohiro Iida, Kanako Yasuda, Masahiro Miura, Annabelle Ayame 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.

Keywords: Anatomic outcomes; Exudative age-related macular degeneration; Functional outcomes; Intravitreal aflibercept; Polypoidal choroidal vasculopathy; Treat-and-extend; Treatment interval.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Absolute BCVA for patients in the PCV subgroup between baseline and week 96. Full analysis set. Last observation carried forward. Boxesshow the IQR (25–75%). The center line of the box and “+” show median and mean values, respectively. The top and bottom of the vertical bars show the maximum and minimum values (where values were within the range of 1.5 IQR); the values that exceed the range of 1.5 IQR were defined as outliers and are shown outside the vertical bars as an “x.” Mean BCVA: IVT-AFL-2W: baseline, 52.7; week 4, 56.7; week 8, 59.3; week 16, 59.3; week 24, 60.2; week 32, 59.8; week 40, 60.1; week 48, 59.8; week 52, 60.1; week 56, 59.3; week 64, 60.0; week 72, 59.9; week 80, 59.3; week 88, 59.3; week 96, 56.3. IVT-AFL-4W: baseline, 57.5; week 4, 59.3; week 8, 62.8; week 16, 65.3; week 24, 65.9; week 32, 65.0; week 40, 64.8; week 48, 65.5; week 52, 65.6; week 56, 64.3; week 64, 64.6; week 72, 63.7; week 80, 63.8; week 88, 62.8; week 96, 62.3. 2W/4W 2-/4-week adjustment, BCVA best-corrected visual acuity, ETDRS Early Treatment Diabetic Retinopathy Study, IQR interquartile range, IVT-AFL intravitreal aflibercept, PCV polypoidal choroidal vasculopathy
Fig. 2
Fig. 2
Change in BCVA from baseline to week 96 in the PCV subgroup. Full analysis set. Last observation carried forward. 2W/4W 2-/4-week adjustment, BCVA best-corrected visual acuity, ETDRS Early Treatment Diabetic Retinopathy Study, PCV polypoidal choroidal vasculopathy
Fig. 3
Fig. 3
Mean change in CRT from baseline to week 96 in the PCV subgroup. Full analysis set. Last observation carried forward. 2W/4W 2-/4-week adjustment, CRT central retinal thickness, IVT-AFL intravitreal aflibercept, PCV polypoidal choroidal vasculopathy

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