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

Abstract

Purpose To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) versus IVT-AFL plus rescue photodynamic therapy (IVT-AFL\u2009+\u2009rPDT) 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\xa0mg. At week 12, the patients were randomly assigned 1:1 to IVT-AFL\u2009+\u2009sham PDT or IVT-AFL\u2009+\u2009rPDT. Patients not requiring rescue received IVT-AFL every 8\xa0weeks; those requiring rescue received IVT-AFL monthly plus sham/active PDT. Following week 52, the treatment intervals could be extended\u2009>\u20098\xa0weeks. Results The baseline demographics for the 159 Japanese patients were balanced. At week 96, the mean BCVA change was\u2009+\u20099.7 (IVT-AFL) versus\u2009+\u20099.5 letters (IVT-AFL\u2009+\u2009rPDT) (least-squares mean difference of −\xa00.3; 95% CI, −\xa03.7 to 3.1); the mean central subfield thickness reduction was −\xa0148.0\xa0µm versus −\xa0145.9\xa0µm. Overall, 17.1% of the patients required rescue PDT. At week 96, 25.0% (IVT-AFL) and 37.9% (IVT-AFL\u2009+\u2009rPDT) of the patients had complete polyp regression; 84.1% (IVT-AFL) and 88.4% (IVT-AFL\u2009+\u2009rPDT) 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\u2009+\u2009rPDT). Overall, 36.0% (IVT-AFL) and 33.8% (IVT-AFL\u2009+\u2009rPDT) 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.