Dexamethasone Intravitreal Implant in Combination with Laser Photocoagulation for the Treatment of Diffuse Diabetic Macular Edema
Dexamethasone Intravitreal Implant in Combination with Laser Photocoagulation for the Treatment of Diffuse Diabetic Macular Edema
复制标题
DOI：
10.1016/j.ophtha.2013.02.018
复制
发表时间：
2013-09-01
期刊：
影响因子：
13.7
通讯作者：
Whitcup, Scott M.
中科院分区：
文献类型：
--
作者：
Callanan, David G.;Gupta, Sunil;Whitcup, Scott M.
用途：评价Ozurdex（地塞米松玻璃体内植入物[DEX植入物]; Allergan，Inc，Irvine，CA）0.7 mg联合激光光凝与单独激光治疗弥漫性糖尿病黄斑水肿（DME）的比较。设计：随机、对照、多中心、双盲、平行组、12个月试验。参与者：253例至少1只眼弥漫性DME导致视网膜增厚和视力受损的患者干预：患者被随机分配到研究眼，在基线时使用DEX植入物治疗，在第1个月时使用激光治疗。（联合治疗; n = 126）或基线时的假植入和第1个月时的激光（单纯激光; n = 127），并可根据需要接受最多3次额外激光治疗和1次额外DEX植入或假治疗。主要结果指标：主要疗效变量为第12个月时最佳矫正视力（BCVA）较基线改善10个字母或以上的患者百分比。其他关键疗效变量包括BCVA较基线的变化和荧光素血管造影评价的血管渗漏面积。安全性变量包括不良事件和眼内压。结果：治疗12个月时BCVA增加10个字母或更多的患者百分比在治疗组之间没有差异，但联合组在第1个月时的患者百分比显著增加（P
Purpose: To evaluate Ozurdex (dexamethasone intravitreal implant [DEX implant]; Allergan, Inc, Irvine, CA) 0.7 mg combined with laser photocoagulation compared with laser alone for treatment of diffuse diabetic macular edema (DME).Design: Randomized, controlled, multicenter, double-masked, parallel-group, 12-month trial.Participants: Two hundred fifty-three patients with retinal thickening and impaired vision resulting from diffuse DME in at least 1 eye (the study eye) were enrolled.Intervention: Patients were randomized to treatment in the study eye with DEX implant at baseline plus laser at month 1 (combination treatment; n = 126) or sham implant at baseline and laser at month 1 (laser alone; n = 127) and could receive up to 3 additional laser treatments and 1 additional DEX implant or sham treatment as needed.Main Outcome Measures: The primary efficacy variable was the percentage of patients who had a 10-letter or more improvement in best-corrected visual acuity (BCVA) from baseline at month 12. Other key efficacy variables included the change in BCVA from baseline and the area of vessel leakage evaluated with fluorescein angiography. Safety variables included adverse events and intraocular pressure (IOP).Results: The percentage of patients who gained 10 letters or more in BCVA at month 12 did not differ between treatment groups, but the percentage of patients was significantly greater in the combination group at month 1 (P