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Hata, Masayuki MD*; Oishi, Akio MD, PhD*; Yamashiro, Kenji MD, PhD*; Ooto, Sotaro MD, PhD*; Tamura, Hiroshi MD, PhD*; Nakanishi, Hideo MD, PhD*; Ueda-Arakawa, Naoko MD*; Akagi-Kurashige, Yumiko MD, PhD*; Kuroda, Yoshimasa MD*; Takahashi, Ayako MD*; Tsujikawa, Akitaka MD, PhD; Yoshimura, Nagahisa MD, PhD*

doi: 10.1097/IAE.0000000000001370
Original Study

Purpose: To investigate the incidence rate, risk factors, and final outcomes of patients with age-related macular degeneration (AMD) who have experienced vision loss despite periodic aflibercept treatment.

Methods: Subjects with treatment-naive AMD were prospectively recruited and treated with three monthly injections followed by two monthly injections of aflibercept. The incidence rate and risk factors of more than two lines of vision loss at any visit were investigated.

Results: We included 196 eyes of 196 patients. Vision loss was observed in 16 patients (8.2%). Eleven of 16 patients developed vision loss during the initial 3 months (68.8%). Vision loss remained in 11 eyes (68.8%) at the final visit. The maximum pigment epithelium detachment (PED) height (odds ratio = 1.46 for a 100-μm increase in the PED height) and disruption of the external limiting membrane (odds ratio = 4.45) were identified as risk factors for developing vision loss on logistic regression analysis.

Conclusion: The incidence rate of vision loss during aflibercept treatment was relatively low. Identifying high-risk patients, those with a high PED height and disruption of the external limiting membrane, would be helpful in ensuring appropriate informed consent before treatment. Further studies are needed to establish optimal treatment for these patients.

Despite intensive treatment with aflibercept injections, 8.2% of patients with age-related macular degeneration experienced 2 lines of vision loss. High pigment epithelium detachment and disruption of the external limiting membrane at baseline were risk factors for vision loss.

*Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan; and

Department of Ophthalmology, Kagawa University Faculty of Medicine, Miki, Japan.

Reprint requests: Akio Oishi, MD, PhD, Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, 54 Kawahara, Shogoin, Sakyo, Kyoto 606-8507, Japan; e-mail:

Supported in part by a grant-in-aid for scientific research (no. 24791847) from the Japan Society for the Promotion of Science, Tokyo, Japan and the Innovative Techno-Hub for Integrated Medical Bio-Imaging of the Project for Developing Innovation Systems from the Ministry of Education, Culture, Sports, Science, and Technology (MEXT), Tokyo, Japan.

A. Oishi, K. Yamashiro, S. Ooto, A. Takahashi, A. Tsujikawa, and N. Yoshimura received lecture fees from several companies, including Novartis (Basel, Switzerland) and Bayer (Leverkusen, Germany). A. Oishi received financial support from Alcon Japan (Tokyo, Japan). A. Takahashi and A. Tsujikawa received financial support from Pfizer (New York, NY). N. Yoshimura is a consultant of Nidek (Gamagori, Japan) and received financial support from the Topcon Corporation (Tokyo, Japan), Nidek (Tokyo, Japan), and Canon (Tokyo, Japan). The remaining authors have no conflicting interests to disclose.

The organizations had no role in the design or conduct of this research.

© 2017 by Ophthalmic Communications Society, Inc.