Abstract
Purpose :
To assess the safety and effectiveness of intravitreal aflibercept injections (IAI) in wet age-related macular degeneration (wAMD) patients in Japan.
Methods :
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.
Results :
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.
Conclusions :
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.