EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN

Hiroko Terasaki, Kunihiko Shiraki, Masahito Ohji, Carola Metzig, Thomas Schmelter, Oliver Zeitz, Olaf Sowade, Masato Kobayashi, Robert Vitti, Alyson Berliner, Fumio Shiraga

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)938-947
Number of pages10
JournalRetina (Philadelphia, Pa.)
Volume39
Issue number5
DOIs
Publication statusPublished - May 1 2019

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Intravitreal Injections
Macular Edema
Japan
Safety
Lasers
Visual Acuity
aflibercept
Population

ASJC Scopus subject areas

  • Ophthalmology

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EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN. / Terasaki, Hiroko; Shiraki, Kunihiko; Ohji, Masahito; Metzig, Carola; Schmelter, Thomas; Zeitz, Oliver; Sowade, Olaf; Kobayashi, Masato; Vitti, Robert; Berliner, Alyson; Shiraga, Fumio.

In: Retina (Philadelphia, Pa.), Vol. 39, No. 5, 01.05.2019, p. 938-947.

Research output: Contribution to journalArticle

Terasaki, H, Shiraki, K, Ohji, M, Metzig, C, Schmelter, T, Zeitz, O, Sowade, O, Kobayashi, M, Vitti, R, Berliner, A & Shiraga, F 2019, 'EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN', Retina (Philadelphia, Pa.), vol. 39, no. 5, pp. 938-947. https://doi.org/10.1097/IAE.0000000000002100
Terasaki, Hiroko ; Shiraki, Kunihiko ; Ohji, Masahito ; Metzig, Carola ; Schmelter, Thomas ; Zeitz, Oliver ; Sowade, Olaf ; Kobayashi, Masato ; Vitti, Robert ; Berliner, Alyson ; Shiraga, Fumio. / EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN. In: Retina (Philadelphia, Pa.). 2019 ; Vol. 39, No. 5. pp. 938-947.
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AU - Terasaki, Hiroko

AU - Shiraki, Kunihiko

AU - Ohji, Masahito

AU - Metzig, Carola

AU - Schmelter, Thomas

AU - Zeitz, Oliver

AU - Sowade, Olaf

AU - Kobayashi, Masato

AU - Vitti, Robert

AU - Berliner, Alyson

AU - Shiraga, Fumio

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N2 - 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.

AB - 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.

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