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Efficacy and safety of intravitreal aflibercept for polypoidal choroidal vasculopathy: 96-week outcomes in the Japanese subgroup of the PLANET study

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

Abstract

Purpose

To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) versus IVT-AFL plus rescue photodynamic therapy (IVT-AFL + rPDT) in the subgroup of Japanese patients with polypoidal choroidal vasculopathy (PCV) enrolled in the PLANET study.

Study design

A 96-week, double-masked, sham-controlled phase-3b/4 randomized clinical trial conducted at multiple centers from May 2014 to August 2016.

Patients and methods

Patients with PCV (BCVA 73-24 ETDRS letters [20/40–20/320 Snellen]) received 3 initial monthly doses of IVT-AFL 2 mg. At week 12, the patients were randomly assigned 1:1 to IVT-AFL + sham PDT or IVT-AFL + rPDT. Patients not requiring rescue received IVT-AFL every 8 weeks; those requiring rescue received IVT-AFL monthly plus sham/active PDT. Following week 52, the treatment intervals could be extended > 8 weeks.

Results

The baseline demographics for the 159 Japanese patients were balanced. At week 96, the mean BCVA change was + 9.7 (IVT-AFL) versus + 9.5 letters (IVT-AFL + rPDT) (least-squares mean difference of − 0.3; 95% CI, − 3.7 to 3.1); the mean central subfield thickness reduction was − 148.0 µm versus − 145.9 µm. Overall, 17.1% of the patients required rescue PDT. At week 96, 25.0% (IVT-AFL) and 37.9% (IVT-AFL + rPDT) of the patients had complete polyp regression; 84.1% (IVT-AFL) and 88.4% (IVT-AFL + rPDT) of the patients had no evidence of active polyps. The mean number of injections (weeks 52–96) were 4.6 (IVT-AFL) and 4.5 (IVT-AFL + rPDT). Overall, 36.0% (IVT-AFL) and 33.8% (IVT-AFL + rPDT) of the patients experienced ocular treatment-emergent adverse events.

Conclusion

IVT-AFL monotherapy was efficacious for the treatment of Japanese patients with PCV, and the addition of rescue PDT did not show additional benefits.

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Acknowledgements

The authors thank all the patients and investigators who contributed to this study. Medical writing and editorial support for the preparation of this manuscript (under the guidance of the authors) were provided by Mia Cahill (ApotheCom, UK). Mia Cahill has no conflict of interest to declare. The authors thank Zhongqi Zhang, PhD, for providing statistical support.

Funding

Funding was provided by Bayer Consumer Care AG, Basel, Switzerland for the overall study and for medical writing and editorial assistance for this article.

Author information

Authors and Affiliations

  1. Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, 467-8601, Japan

    Yuichiro Ogura

  2. Department of Ophthalmology, Tokyo Women’s Medical University, Tokyo, Japan

    Tomohiro Iida

  3. Nune Eye Hospital, Seoul, South Korea

    Won Ki Lee

  4. Singapore National Eye Centre and Singapore Eye Research Institute, Singapore, Singapore

    Chui Ming Gemmy Cheung

  5. Duke-NUS, National University of Singapore, Singapore, Singapore

    Chui Ming Gemmy Cheung

  6. University of Sydney, Westmead Institute for Medical Research, Sydney, Australia

    Paul Mitchell

  7. Bayer Consumer Care AG, Basel, Switzerland

    Sergio Leal

  8. Bayer Pharmaceuticals, Berlin, Germany

    Thomas Schmelter

  9. Department of Ophthalmology, Kyushu University, Fukuoka, Japan

    Tatsuro Ishibashi

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Contributions

All authors take full responsibility for the content and scientific accuracy of the manuscript and the online supplementary materials. YO conception and design of the study, drafting of the manuscript, and administrative supervision. TI conception and design of the study, acquisition of data, critical review of intellectual content, and administrative supervision. WKL conception and design of the study, acquisition of data, critical review of intellectual content, and administrative supervision. CMGC analysis and interpretation of the data, critical review of intellectual content, and administrative supervision. PM acquisition of data, analysis and interpretation of the data, critical review of intellectual content, and administrative supervision. SL conception and design of the study, analysis and interpretation of the data, drafting of the manuscript, critical review of intellectual content, obtaining funding, and administrative supervision. TS analysis and interpretation of the data, critical review of intellectual content, and administrative supervision. TI conception and design of the study, acquisition of data, critical review of intellectual content, and administrative supervision.

Corresponding author

Correspondence to Yuichiro Ogura.

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Conflicts of interest

Y. Ogura, Grant (Novartis, Santen, Boehringer Ingelheim), Consultant fee (Novartis, Santen, Senju, HOYA, Alcon Japan, Kowa, Jansen, Boehringer Ingelheim, Astellas), Lecture fee (Santen, Nikon, Wakamoto, Otsuka)  and personal fees from Bayer in relation to the conduct of the PLANET study; T. Iida, Consultant fee, Advisory board member (Bayer, Novartis, Alcon Pharma, Chugai, Kowa); W. K. Lee, Consultant fee (Novartis, Bayer, Roche, Boehringer Ingelheim, Santen); C. M. G. Cheung, Consultant fee (Bayer, Novartis, Roche, Boehringer Ingelheim, Allergan), Lecture fee (Topcon, Zeiss), Grant (Bayer, Novartis, Topcon, Boehringer Ingelheim, Zeiss), Nonfinancial support (Bayer, Novartis, Roche, Topcon, Boehringer Ingelheim); P. Mitchell, Consultant fee, Advisory board member (Bayer, Novartis, Allergan, Mylan); S. Leal, Employee, Stockholder (Bayer Consumer Care AG, Pharmaceuticals, Basel, Switzerland), Patent WO2018/229034 pending); T. Schmelter, Employee, Stockholder (Bayer AG, Berlin, Germany); T. Ishibashi, Consultant fee, Advisory board member (Bayer, Novartis, Alcon Pharma, HOYA, Kowa, Bausch + Lomb).

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Corresponding Author: Yuichiro Ogura

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Ogura, Y., Iida, T., Lee, W.K. et al. Efficacy and safety of intravitreal aflibercept for polypoidal choroidal vasculopathy: 96-week outcomes in the Japanese subgroup of the PLANET study. Jpn J Ophthalmol 65, 344–353 (2021). https://doi.org/10.1007/s10384-020-00805-5

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  • DOI: https://doi.org/10.1007/s10384-020-00805-5

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