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Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.

Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study.

Author information

  • 1Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
  • 2Department of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • 3Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
  • 4Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan.
  • 5Department of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan.
  • 6Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan.
  • 7Bayer Yakuhin, Ltd., Osaka, Japan.
  • 8Bayer HealthCare Pharmaceuticals, Berlin, Germany.
  • 9Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
  • 10Vienna Reading Center (VRC), Medical University of Vienna, Vienna, Austria.
  • 11Oxford Eye Hospital, University of Oxford, Oxford, UK.

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.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

KEYWORDS:

Angiogenesis; Clinical Trial; Macula; Neovascularisation; Retina

[PubMed - indexed for MEDLINE]
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