Vision-related quality of life in Japanese patients with wet age-related macular degeneration treated with intravitreal aflibercept in a real-world setting
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To evaluate vision-related quality of life (QoL) in wet age-related macular degeneration (wAMD) patients receiving intravitreal aflibercept (IVT-AFL).
Prospective, observational Japanese postmarketing surveillance study.
All decisions were made by the treating physician. QoL was assessed using the 25-item National Eye Institute-Visual Functioning Questionnaire (NEI-VFQ-25) composite score administered at baseline, 6 months, and 12 months (primary assessment). Secondary assessments included NEI-VFQ-25 subscale scores, resource use, and best-corrected visual acuity (BCVA; logarithm of the minimum angle of resolution [logMAR]).
In total, 576 patients (baseline), 555 patients (6 months), and 446 patients (12 months) were included. The mean (SD) number of IVT-AFL injections was 3.5 (1.2) at 6 months and 4.6 (2.2) at 12 months. The mean (SD) improvement from baseline in the NEI-VFQ-25 composite score was 3.1 (11.1) at 6 months and 2.7 (12.3) at 12 months (P < .0001). For the NEI-VFQ-25 subscale scores, the mean change was ≥ 4 (minimally important difference) for general vision, near vision, and mental health at 6 months, and for general vision and mental health at 12 months (all P < .0001). A significant improvement from baseline was found in mean BCVA (logMAR) at 6 months (-0.1) and 12 months (-0.1) (P < .0001). The mean change from baseline in the NEI-VFQ-25 scores was greatest in patients with improved BCVA (gain of ≤ -0.3 logMAR units or ≥ 15 letters) after treatment.
IVT-AFL was associated with significant improvements in QoL and visual acuity in Japanese patients with wAMD in a real-world setting.
KeywordsIntravitreal aflibercept NEI-VFQ-25 Wet age-related macular degeneration J-PMS
The statistical analyses were performed by CMIC and were funded by Bayer Yakuhin. Medical writing assistance was provided by PAREXEL and funded by Bayer Yakuhin. Study group investigators: The Participating Investigators were Tsukasa Hanemoto, Kazuaki Nishijima, Hisashi Matsubara, Harumi Wakiyama, Sachio Kawashima, Hiroaki Sato, Shigeki Tagawa, Toyohisa Yoshizawa, Toshiaki Kurakazu, Kenji Inoue, Takatomo Miyake, Koichi Ota, Kunihiko Shiraki, Yoshihide Nakai, Yasuo Kurimoto, Shunji Kusaka, Shigeru Hoshiai, Akihiko Ohira, Masahiro Morimoto, Hitoshi Tabuchi, Kaori Sato, Yasushi Inoue, Sakura Sato, Naomichi Katai, Akira Obana, Junkichi Kabayama, Hidetaka Yamaji, Shiro Ozaki, Jun Sueda, Hidetoshi Hanasaki, Tadayuki Nishide, Hirofumi Yonezawa, Koji Kawamoto, Hidenori Kamimoto, Atsushi Hayashi, Miki Honda, Masahiro Miura, Ryo Obata, Isao Saito, Hideyasu Oh, Takatoshi Maeno, Kazuki Ishibashi, Yoko Fukushima, Taiji Sakamoto, Akiteru Kawahara, Tetsuo Ogino, Jun Arai, Hiroyuki Sato, Yosuke Ida, Satoshi Nakamura, Hirotaka Yokouchi, Misa Suzuki, Kazuyuki Hara, Yasukazu Hino, Ryo Watanabe, Keiichi Mitarai, Kazuhisa Miyamoto, Masayuki Akimoto, Kiyoshi Ishii, Hitoshi Takagi, Naotaka Kanda, Takeo Fukuchi, Masahiro Kaneda, Hiroki Tsujinaka, Hisaharu Suzuki, Yasuhiro Tanifuji, Akinori Uemura, Tsunehiko Ikeda, Hiroko Imaizumi, Kenji Yoshida, Susumu Ishida, Tomoki Sakuraba, and Yukihiro Horie. All Participating Investigators provided and cared for the study patients and collected data.
Conflicts of interest
F. Gomi, Honorarium (Bayer, Alcon, Novartis, Santen, Senju), Speaker fee (Alcon, Bayer, Santen, Senju), Advisory board fee (Alcon, Bayer, Senju), Grant (Alcon, Bayer, Johnson and Johnson, Nidek, Novartis, Pfizer, Santen, Senju), H. Migita, Employee (Bayer); T. Sakaguchi, Employee (Bayer); H. Okada, Consultant fee (Bayer); T. Sugawara, Consultant fee (Bayer); Y. Hikichi, Employee (Bayer).
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