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Won Ki Lee, Yuichiro Ogura, Tomohiro Iida, Shih-Jen Chen, Tien Yin Wong, Paul Mitchell, Tatsuro Ishibashi, eric zhang, Sergio Leal; Efficacy and Safety of Intravitreal Aflibercept in Polypoidal Choroidal Vasculopathy: 12-Month Results of the PLANET Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1199.
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The aim of the PLANET study is to evaluate the efficacy, safety, and tolerability of intravitreal aflibercept injection (IAI) monotherapy compared with IAI plus photodynamic therapy (PDT) in patients with PCV.
PLANET was a randomized, double-masked, sham-controlled, Phase 3b/4 study conducted at 62 sites primarily in Asia. The primary endpoint was the mean change in best-corrected visual acuity from baseline to Week 52. All patients received IAI 2 mg every month for the first 3 months. At Week 12 all patients were randomized 1:1 to IAI 2 mg plus sham PDT (monotherapy) or IAI 2 mg plus active PDT groups. Stratification at randomization was based on qualification for rescue therapy at Week 12 and by ethnicity (Japanese or non-Japanese).
Overall 333 patients were recruited, and 318 were randomized (full analysis set). Baseline demographics/characteristics were similar between groups: 69.8% were male; mean age was 70.6 years. For the primary endpoint, IAI monotherapy (+10.7 letters) was noninferior to IAI plus active PDT (+10.8 letters) at Week 52 (95% CI [–2.9 to 1.6]). The vast majority of patients in the IAI monotherapy and IAI plus active PDT groups did not require rescue therapy (87.9% vs 85.7%, respectively; P=0.84]) and received only IAI 2 mg 8 weekly after 3 monthly doses. The proportions of patients without active polyps at Week 52 were 81.7% and 88.9%. Rates of complete polyp regression by indocyanine green angiography were similar for patients in the IAI monotherapy and IAI plus active PDT groups at Week 52 (38.9% vs 44.8%, respectively; P=0.32). The incidence of ocular treatment-emergent adverse events (AEs) was similar in the IAI monotherapy and IAI plus active PDT groups at Week 52 (31.2% vs 29.2%, respectively). The most common ocular AEs in each group were conjunctival hemorrhage (5.1%) and dry eye (5.6%), respectively. There were no differences in the incidence of Anti-Platelet Trialists Collaboration–defined arterial thromboembolic events between treatments.
IAI monotherapy is an effective treatment for patients with PCV, with no need for rescue therapy in >85% of patients. In this study, IAI monotherapy was noninferior to IAI plus active PDT and more than 80% of patients had no signs of polyp activity at Week 52. The safety profile of IAI was consistent with that seen in previous studies.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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