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Vision-related quality of life in Japanese patients with wet age-related macular degeneration treated with intravitreal aflibercept in a real-world setting

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To evaluate vision-related quality of life (QoL) in wet age-related macular degeneration (wAMD) patients receiving intravitreal aflibercept (IVT-AFL).

Study design

Prospective, observational Japanese postmarketing surveillance study.

Methods

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]).

Results

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.

Conclusion

IVT-AFL was associated with significant improvements in QoL and visual acuity in Japanese patients with wAMD in a real-world setting.

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Acknowledgments

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 Tsu**aka, 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.

Author information

Authors and Affiliations

  1. Hyogo College of Medicine Hospital, Hyogo, Japan

    Fumi Gomi

  2. Bayer Yakuhin, Osaka, Japan

    Hideyuki Migita, Toshiaki Sakaguchi & Yusuke Hikichi

  3. CMIC Co, Ltd, Tokyo, Japan

    Hiromi Okada & Tamotsu Sugawara

Authors
  1. Fumi Gomi
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  2. Hideyuki Migita
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  3. Toshiaki Sakaguchi
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  4. Hiromi Okada
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  5. Tamotsu Sugawara
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  6. Yusuke Hikichi
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Consortia

the Participating Investigators

  • 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 Tsu**aka
  • , Hisaharu Suzuki
  • , Yasuhiro Tanifuji
  • , Akinori Uemura
  • , Tsunehiko Ikeda
  • , Hiroko Imaizumi
  • , Kenji Yoshida
  • , Susumu Ishida
  • , Tomoki Sakuraba
  •  & Yukihiro Horie

Corresponding author

Correspondence to Yusuke Hikichi.

Ethics declarations

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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Corresponding Author: Yusuke Hikichi

The members of The Participating Investigators are listed in “Acknowledgements” section.

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Cite this article

Gomi, F., Migita, H., Sakaguchi, T. et al. Vision-related quality of life in Japanese patients with wet age-related macular degeneration treated with intravitreal aflibercept in a real-world setting. Jpn J Ophthalmol 63, 437–447 (2019). https://doi.org/10.1007/s10384-019-00687-2

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  • DOI: https://doi.org/10.1007/s10384-019-00687-2

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