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R Mori, M Ohji, K Takahashi, Tatsuro Ishibashi, H Migita, T Sakaguchi, L Inuyama, M Yuzawa; Intravitreal aflibercept in wet age-related macular degeneration patients from Japan: 6-month outcomes of J-PMS. Invest. Ophthalmol. Vis. Sci. 2016;57(12):536.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and effectiveness of intravitreal aflibercept injections (IAI) in wet age-related macular degeneration (wAMD) patients in Japan.
J-PMS is a postmarketing surveillance study with postapproval commitment by the Japanese authority. It is a prospective, multicenter, observational study that is monitoring 36-month outcomes following IAI treatment in routine clinical practices in Japan. Safety (primary outcome) and visual and anatomic outcomes were assessed in a planned 6-month interim analysis, which is reported here. The decision to treat (or switch) to IAI was made by the patient’s own physician.
1636 wAMD patients provided safety data and 1610 patients provided efficacy data. The mean age of patients was 74.2 years, 69.8% were male, 70.6% had choroidal neovascularization (CNV), 45.0% had polypoidal choroidal vasculopathy, and 42.5% had comorbidities, including hypertension (29.3%). Most patients (58.9%) were treatment naïve and, among previously treated patients, the main reason for switching was insufficient response to other anti-vascular endothelial growth factor agents (76.4%). The mean number of IAI injections was 3.5 at 6 months. Serious adverse events (SAEs) were reported in 17 patients (1.0%). The most common ocular SAEs were vitreous hemorrhage (0.2%), retinal pigment epithelial tear (0.2%), and retinal detachment (0.2%), and the most common nonocular SAE was myocardial infarction (0.1%). The mean change in best-corrected visual acuity (BCVA) (logMAR) was -0.132 (6.6 letters) at Month 6. Vision was maintained (BCVA change >-0.3 to <0.3) or improved (BCVA change ≤-0.3) in 78.1% and 18.5% of patients at Month 6, respectively. The mean reduction in central retinal thickness was -103.8 µm at Month 6. IAI was effective in treatment-naïve and previously treated patients (Table) and across wAMD subtypes.
Ocular SAEs were consistent with the known safety profile of IAI. Improvements in visual and anatomic outcomes were observed in all groups. The benefits in treatment-naïve patients were comparable to VIEW.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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