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Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study
  1. Yuichiro Ogura1,
  2. Hiroko Terasaki2,
  3. Fumi Gomi3,
  4. Mitsuko Yuzawa4,
  5. Tomohiro Iida5,
  6. Miki Honda6,
  7. Koichi Nishijo7,
  8. Olaf Sowade8,
  9. Tetsushi Komori7,
  10. Ursula Schmidt-Erfurth9,
  11. Christian Simader10,
  12. Victor Chong11
  13. for the VIEW 2 Investigators
  1. 1Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  2. 2Department of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan
  3. 3Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan
  4. 4Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan
  5. 5Department of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan
  6. 6Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan
  7. 7Bayer Yakuhin, Ltd., Osaka, Japan
  8. 8Bayer HealthCare Pharmaceuticals, Berlin, Germany
  9. 9Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria
  10. 10Vienna Reading Center (VRC), Medical University of Vienna, Vienna, Austria
  11. 11Oxford Eye Hospital, University of Oxford, Oxford, UK
  1. Correspondence to Dr Yuichiro Ogura, Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya-shi, Aichi-ken 467-8602, Japan; vitreous.surgeon{at}gmail.com

Abstract

Background/aims To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial.

Methods In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52.

Results At week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups.

Conclusions IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population.

Trial registration number NCT00637377.

  • Angiogenesis
  • Clinical Trial
  • Macula
  • Neovascularisation
  • Retina

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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