Department of Ophthalmology, Nagoya University Hospital, Nagoya, Japan.
Department of Ophthalmology and Visual Sciences, Osaka City University, Osaka, Japan.
Retina. 2019 May;39(5):938-947. doi: 10.1097/IAE.0000000000002100.
To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME).
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.
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.
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.
评估玻璃体内注射阿柏西普（IAI）治疗糖尿病黄斑水肿（DME）日本患者的疗效和安全性。
VIVID-DME 是一项 3 期研究，包括按 1:1:1 比例随机分组的 DME 患者，分别接受 IAI 2mg 每 4 周（2q4）、IAI 2mg 每 4 周至第 16 周，然后 8 周给药（2q8）和激光治疗。本研究共纳入 403 例患者（76 例日本患者）。VIVID-Japan（72 例；均为日本患者）是一项非随机、开放性研究，包括接受 IAI 2q4 治疗至第 16 周，然后 2q8 治疗的 DME 日本患者。VIVID-DME 的主要疗效终点（第 52 周）为最佳矫正视力（BCVA）从基线的平均变化；VIVID-Japan 评估安全性和耐受性。
2q4、2q8 和激光组的最佳矫正视力（字母）平均变化分别为+10.6、+10.9 和+1.2，以及+9.8、+9.5 和+1.1，在 VIVID-DME 的非日本人群和日本人群中。在 VIVID-Japan 中，IAI 2q8 的平均变化为+9.3。玻璃体内注射阿柏西普也为解剖学结果提供了一致优于激光的获益。不良反应与 IAI 的已知安全性特征一致。
在 DME 日本患者中，IAI 治疗在视觉和解剖学结果方面优于激光，并且在疗效和安全性方面的结果与非日本患者人群相似。
