Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study

作者：Won Ki Lee, Tomohiro Iida, Yuichiro Ogura, Shih‐Jen Chen, Tien Yin Wong, Paul Mitchell, Chui Ming Gemmy Cheung, Zhongqi Zhang, Sérgio Leal, Tatsuro Ishibashi, for the PLANET Investigators · 发表于：JAMA Ophthalmology · 年份：2018 · DOI：10.1001/jamaophthalmol.2018.1804 · 被引用次数：270 · 研究领域：Retinal Diseases and Treatments、Ocular Diseases and Behçet’s Syndrome、Ophthalmology and Visual Impairment Studies

Importance: Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed. Objective: To evaluate intravitreal aflibercept injection (IAI) in participants with PCV and compare IAI monotherapy with IAI plus rescue photodynamic therapy (PDT). Design, Setting, and Participants: This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers in Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, and Taiwan from May 2014 to August 2016, and included adults 50 years or older with symptomatic macular PCV and a best-corrected visual acuity of 73 to 24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent). Interventions: Participants received 2 mg of IAI at weeks 0, 4, and 8. At week 12, participants with a suboptimal response were randomized 1:1 to receive IAI plus sham PDT (IAI monotherapy) or a "rescue" of IAI plus rescue PDT (IAI/PDT). Participants who did not qualify for rescue received IAI every 8 weeks; those qualifying for rescue received IAI every 4 weeks plus sham/active PDT. When the rescue criteria were no longer met, injection intervals were gradually extended to 8 weeks. Main Outcomes and Measures: Noninferiority of IAI monotherapy to IAI/PDT for mean change in best-corrected visual acuity from baseline to week 52 (95% CI of the difference entirely above -5 letters). Results: Of the 318 participants, the...