One-Year Outcomes of the DA VINCI Study of VEGF Trap-Eye in Eyes with Diabetic Macular Edema
One-Year Outcomes of the DA VINCI Study of VEGF Trap-Eye in Eyes with Diabetic Macular Edema
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DOI：
10.1016/j.ophtha.2012.02.010
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发表时间：
2012-08-01
期刊：
影响因子：
13.7
通讯作者：
Heier, Jeff S.
中科院分区：
文献类型：
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作者：
Do, Diana V.;Quan Dong Nguyen;Heier, Jeff S.
目的：比较血管内皮生长因子 (VEGF) Trap-Eye 与激光光凝治疗糖尿病性黄斑水肿 (DME) 眼的不同剂量和给药方案。设计：随机、双盲、多中心、2 期临床试验。参与者：患有中心参与 DME 的糖尿病患者 (n = 221)。方法：参与者被随机分配至 5 种治疗方案中的 1 种：VEGF Trap-Eye 每 4 周 0.5 mg (0.5q4)；每 4 周 2 毫克 (2q4)； 3 次每月初始剂量后，每 8 周 2 毫克 (2q8)；或在 3 次初始每月剂量 (2PRN) 或黄斑激光光凝后根据需要服用 2 mg 剂量。 主要结果指标：24 周（主要终点）和 52 周时最佳矫正视力 (BCVA) 的变化、糖尿病视网膜病变早期治疗研究 (ETDRS) BCVA 中获得 15 个或更多字母的眼睛比例，以及中央视网膜厚度 (CRT) 的平均变化结果：如之前报道，第 24 周时，0.5q4、2q4、2q8 和 2PRN 方案的 VEGF Trap-Eye 组 BCVA 平均改善分别为 8.6、11.4、8.5 和 10.3 个字母，而激光组为 2.5 个字母（P
Purpose: To compare different doses and dosing regimens of Vascular Endothelial Growth Factor (VEGF) Trap-Eye with laser photocoagulation in eyes with diabetic macular edema (DME).Design: Randomized, double-masked, multicenter, phase 2 clinical trial.Participants: Diabetic patients (n = 221) with center-involved DME.Methods: Participants were assigned randomly to 1 of 5 treatment regimens: VEGF Trap-Eye 0.5 mg every 4 weeks (0.5q4); 2 mg every 4 weeks (2q4); 2 mg every 8 weeks after 3 initial monthly doses (2q8); or 2 mg dosing as needed after 3 initial monthly doses (2PRN), or macular laser photocoagulation.Main Outcome Measures: The change in best-corrected visual acuity (BCVA) at 24 weeks (the primary end point) and at 52 weeks, proportion of eyes that gained 15 letters or more in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA, and mean changes in central retinal thickness (CRT) from baseline.Results: As previously reported, mean improvements in BCVA in the VEGF Trap-Eye groups at week 24 were 8.6, 11.4, 8.5, and 10.3 letters for 0.5q4, 2q4, 2q8, and 2PRN regimens, respectively, versus 2.5 letters for the laser group (P