Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland, USA.
Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5.
To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME).
Multicenter, randomized, double-masked, phase 2 clinical trial.
A total of 221 diabetic patients with clinically significant macular edema involving the central macula.
Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter.
Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks.
Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters versus only +2.5 letters in the laser group (P ≤ 0.0085 for each VEGF Trap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were seen in up to 93%, 64%, and 34% of VEGF Trap-Eye groups versus up to 68%, 32%, and 21% in the laser group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from -127.3 to -194.5 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. laser). VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye were generally consistent with those seen with other intravitreal anti-VEGF agents.
Intravitreal VEGF Trap-Eye produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME.
比较不同剂量和不同给药方案的玻璃体内血管内皮生长因子（VEGF）陷阱眼内注射与黄斑水肿（DME）患者的局部/格栅光凝治疗的效果。
多中心、随机、双盲、二期临床试验。
共 221 名糖尿病患者，其临床显著的黄斑水肿累及中心黄斑。
患者被分配到以下 5 种治疗方案之一：每 4 周 0.5 毫克 VEGF 陷阱眼内注射；每 4 周 2 毫克 VEGF 陷阱眼内注射；前 3 个月每月 2 毫克 VEGF 陷阱眼内注射，然后每 8 周注射一次；前 3 个月每月 2 毫克 VEGF 陷阱眼内注射，然后按需（PRN）注射；或黄斑激光光凝。在基线和此后的每 4 周进行评估。
24 周时视力和中央视网膜厚度（CRT）的平均变化。
4 个 VEGF 陷阱眼内注射组的患者视力平均提高 8.5 至 11.4 个早期糖尿病视网膜病变研究（ETDRS）字母，而激光组仅提高 2.5 个字母（每个 VEGF 陷阱眼内注射组与激光组相比，P ≤ 0.0085）。VEGF 陷阱眼内注射组高达 93%、64%和 34%的患者从基线开始获得了 0+、10+和 15+字母的提高，而激光组分别为 68%、32%和 21%。4 个 VEGF 陷阱眼内注射组的 CRT 平均降低 127.3 至 194.5 微米，而激光组仅降低 67.9 微米（每个 VEGF 陷阱眼内注射组与激光组相比，P = 0.0066）。VEGF 陷阱眼内注射通常具有良好的耐受性。接受 VEGF 陷阱眼内注射治疗的患者的眼部不良反应与其他玻璃体内抗 VEGF 药物相似。
与黄斑激光光凝相比，玻璃体内 VEGF 陷阱眼内注射在 DME 患者中显著改善了视力，具有临床意义。
