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

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.

Figures

Fig. 1.
Fig. 1.
Patient disposition in VIVID-DME and VIVID-Japan. *Of the 73 patients assigned to treatment, one patient withdrew consent and was excluded from the analyses. 2q8, 2 mg every 4 weeks (2q4) from baseline to Week 16 (5 doses) followed by dosing every 8 weeks through Week 48; FAS, full analysis set; SAS, safety analysis set.
Fig. 2.
Fig. 2.
Mean change from baseline to Week 52 in BCVA (ETDRS letters) in the non-Japanese population (VIVID-DME) (A), Japanese population (VIVID-DME) (B), and Japanese population (VIVID-Japan) (C). 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; LOCF, last observation carried forward.
Fig. 3.
Fig. 3.
Proportion of patients (%) who gained or lost ≥5, ≥10, or ≥15 ETDRS letters at Week 52 in the non-Japanese population (VIVID-DME) (A), Japanese population (VIVID-DME) (B), and Japanese population (VIVID-Japan) (C). Note that data for ≥5-letter gain were not studied in VIVID-Japan. 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; LOCF, last observation carried forward.
Fig. 4.
Fig. 4.
Mean change from baseline to Week 52 in CRT (µm) in The non-Japanese population (VIVID-DME) (A), Japanese population (VIVID-DME) (B), and Japanese population (VIVID-Japan) (C). 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; LOCF, last observation carried forward.

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