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Terasaki, Hiroko, MD, PhD*; Shiraki, Kunihiko, MD, PhD; Ohji, Masahito, MD, PhD; Metzig, Carola, MD§; Schmelter, Thomas, PHD§; Zeitz, Oliver, MD§; Sowade, Olaf, MD§; Kobayashi, Masato, MD, PhD; Vitti, Robert, MD**; Berliner, Alyson, MD, PhD**; Shiraga, Fumio, MD, PhD††

doi: 10.1097/IAE.0000000000002100
Original Study: PDF Only

Purpose: To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME).

Methods: VIVID-DME was a Phase 3 study comprising patients with DME randomized 1:1:1 to IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 4 weeks until Week 16 then 8-week dosing (2q8), and laser. A total of 403 patients (76 Japanese) were included in this study. VIVID-Japan (72; all Japanese patients) was a nonrandomized, open-label study comprising Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8. Primary efficacy endpoint (Week 52) of VIVID-DME was mean change from baseline in best-corrected visual acuity; VIVID-Japan evaluated safety and tolerability.

Results: Mean change in best-corrected visual acuity (letters) for 2q4, 2q8, and laser groups was +10.6, +10.9, and +1.2 and +9.8, +9.5, and +1.1 in the non-Japanese and Japanese populations of VIVID-DME, respectively. In VIVID-Japan, it was +9.3 for IAI 2q8. Intravitreal aflibercept injection also provided consistently greater benefits for anatomical outcomes versus laser. Adverse events were consistent with the known safety profile of IAI.

Conclusion: In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Intravitreal aflibercept injection was superior to laser for visual and anatomical outcomes in Japanese patients with DME. In addition, intravitreal aflibercept injection resulted in efficacy and safety outcomes similar to those observed in a non-Japanese patient population.

*Department of Ophthalmology, Nagoya University Hospital, Nagoya, Japan;

Department of Ophthalmology and Visual Sciences, Osaka City University, Osaka, Japan;

Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan;

§Bayer AG, Berlin, Germany;

Bayer Pharmaceuticals, Osaka, Japan;

**Regeneron Pharmaceuticals, Tarrytown, New York; and

††Department of Ophthalmology, Okayama University Medical School, Okayama, Japan.

Reprint requests: Hiroko Terasaki, MD, PhD, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan; e-mail:

The VIVID-DME and VIVID-Japan studies were funded by Bayer, Whippany, NJ, and Regeneron Pharmaceuticals, Inc, Tarrytown, NY.

H. Terasaki has financial relationships with Alcon, Bayer, Carl-Zeiss, Hoya, Kowa, Nidek, Novartis, Otsuka, Rohto, Pfizer, Santen, Senju, and Wakamoto; K. Shiraki has financial relationships with Alcon, Bayer, Novartis, Santen, Senju, and Wakamoto; M. Ohji has financial relationships with Alcon, Allergan, Bayer, Carl-Zeiss, Kowa, MSD, Novartis, Otsuka, Pfizer, Santen, Sanwa-Kagaku, Senju, and Shionogi; C. Metzig, T. Schmelter, O. Sowade, and O. Zeitz are all employees of Bayer; M. Kobayashi is an employee of Bayer; F. Shiraga has financial relationships with Alcon, Bayer, Hoya, Novartis, Santen, Senju, Topcon. The remaining authors have no funding or conflicts of interest to disclose.

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© 2019 by Ophthalmic Communications Society, Inc.