September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Intravitreal aflibercept in wet age-related macular degeneration patients from Japan: 6-month outcomes of J-PMS
Author Affiliations & Notes
  • R Mori
    Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan
  • M Ohji
    Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan
  • K Takahashi
    Department of Ophthalmology, Kansai Medical University, Hirakata Hospital, Osaka, Japan
  • Tatsuro Ishibashi
    Kyushu University Hospital, Fukuoka, Japan
  • H Migita
    Medical Affairs, Bayer Yakuhin Ltd., Osaka, Japan
  • T Sakaguchi
    Medical Affairs, Bayer Yakuhin Ltd., Osaka, Japan
  • L Inuyama
    Medical Affairs, Bayer Yakuhin Ltd., Osaka, Japan
  • M Yuzawa
    Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan
  • Footnotes
    Commercial Relationships   R Mori, Bayer (F); M Ohji, Bayer (C), Bayer (F); K Takahashi, Bayer (C), Bayer (F); Tatsuro Ishibashi, Bayer (C), Bayer (F); H Migita, Bayer (E); T Sakaguchi, Bayer (E); L Inuyama, Bayer (E); M Yuzawa, Bayer (C), Bayer (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science September 2016, Vol.57, 536. doi:
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    • Get Citation

      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)

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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.

 

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