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

Yuichiro Ogura, Tomohiro Iida, Won Ki Lee, Chui Ming Gemmy Cheung, Paul Mitchell, Sergio Leal, Thomas Schmelter, Tatsuro Ishibashi

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalJapanese Journal of Ophthalmology
DOIs
Publication statusAccepted/In press - 2021

All Science Journal Classification (ASJC) codes

  • Ophthalmology

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