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Kanji Takahashi,1 Masahito Ohji,2 Hiroko Terasaki,3 Shigeru Honda,4 Philippe Margaron,5 Tadhg Guerin,6 Mitsuko Yuzawa,7 On behalf of the EVEREST II Japanese investigators 1Department of Ophthalmology, Kansai Medical University, Osaka, Japan; 2Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan; 3Department of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan; 4Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan; 5Department of Ophthalmology, Novartis Pharma AG, Basel, Switzerland; 6Department of Ophthalmology, Novartis Ireland Limited, Dublin, Ireland; 7Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan Purpose: To compare the efficacy and safety of ranibizumab 0.5 mg with or without verteporfin photodynamic therapy in Japanese patients with polypoidal choroidal vasculopathy over 12 months. Study design: EVEREST II was a 24-month, Phase IV, multicenter, randomized, double-masked study in Asian patients with symptomatic macular polypoidal choroidal vasculopathy. Methods: Of the 322 enrolled patients, 84 patients, including 46 patients who received ranibizumab + verteporfin photodynamic therapy (combination therapy arm) and 38 patients who received ranibizumab/sham PDT (monotherapy arm), were Japanese who were evaluated in this subanalysis. Mean change in best-corrected visual acuity (BCVA) and complete polyp regression at Month 12, ranibizumab treatment exposure, and safety over 12 months were assessed. Results: Baseline demographics were well balanced between the arms. At Month 12, mean change in BCVA letter score was +8.5 with combination therapy versus +6.4 with monotherapy. Complete polyp regression was higher with combination therapy than with monotherapy at Month 12 (70.5% vs 27.3%). Over 12 months, patients in the combination arm received a median of 4.0 ranibizumab injections vs 7.0 in the monotherapy arm. Serious adverse events were generally low in both arms, and retinal hemorrhage, an adverse event, was reported in one patient (2.2%). Conclusion: The results from the Japanese cohort were in agreement with the EVEREST II study. Combination therapy was effective in improving BCVA and achieving a higher rate of complete polyp regression with a lower number of ranibizumab injections than monotherapy. No new safety signals were reported, and safety events were comparable between both arms over 12 months. Keywords: Japanese, polypoidal choroidal vasculopathy, ranibizumab, neovascular age-related macular degeneration, verteporfin photodynamic therapy |
