Maturi, R.K., Glassman, A.R., Liu, D., et al.
地塞米松 中加 黄斑
设计、设置和参与者： 第二期多中心随机临床试验于2014年2月至2016年12月间在美国40个地点，116名糖尿病患者的129只眼镜上进行。视力在20/32至20/320之间有持续的糖尿病黄斑水肿(DME)的眼睛，在进入试验阶段之前至少有3次抗血管内皮生长因子(anti-VEGF)治疗注射，其中包括另外的每3个月一次的0.3 mg的雷珠单抗注射剂。根据意向性治疗进行数据分析。
干预：在试验阶段后，基于一个结构化的重复处理实验方法，除了每4周在两种治疗组中持续0.3 mg 雷珠单抗治疗的基础上，对原本符合资格的有持续的糖尿病黄斑水肿(DME)的眼睛进行随机分配，分别接受700μg地塞米松(联合治疗组，65只眼)或虚假的治疗(雷珠单抗组，64只眼)
结果：116名随机患者中年龄中位数为65岁(四分位差[IQR]， 58-71岁);50.9%为女性，60.3%为白人。在联合组中，来自雷珠单抗随机化的平均视觉敏锐度(SD)改善为2.7(9.8) letters，而雷珠单抗组为3.0(7.1)letters，调整后的治疗组差异(联合组减去雷珠单抗组) -0.5letter(95% CI， -3.6 - 2.5); 双边P= .73)。联合组中在中心子场厚度平均(SD) 改变是-110(86) μm，而雷珠单抗组为-62 (97) μm (校正差,-52;95% CI， -82到-22;双边P < .001)。在联合组中19只眼(29%)出现了眼压升高现象或开始用降压眼药水治疗，而在雷珠单抗组中这一现象为零(双边P < .001)。
Importance:Some eyes have persistent diabetic macular edema (DME) following anti-vascular endothelial growth factor (anti-VEGF) therapy for DME. Subsequently adding intravitreous corticosteroids to the treatment regimen might result in better outcomes than continued anti-VEGF therapy alone.Objective:To compare continued intravitreous ranibizumab alone with ranibizumab plus intravitreous dexamethasone implant in eyes with persistent DME.Design, Setting, and Participants:Phase 2 multicenter randomized clinical trial conducted at 40 US sites in 129 eyes from 116 adults with diabetes between February 2014 and December 2016. Eyes had persistent DME, with visual acuity of 20/32 to 20/320 after at least 3 anti-VEGF injections before a run-in phase, which included an additional 3 monthly 0.3-mg ranibizumab injections. Data analysis was according to intent to treat.Interventions:Following the run-in phase, study eyes that had persistent DME and were otherwise eligible were randomly assigned to receive 700 μg of dexamethasone (combination group, 65 eyes) or sham treatment (ranibizumab group, 64 eyes) in addition to continued 0.3-mg ranibizumab in both treatment arms as often as every 4 weeks based on a structured re-treatment protocol.Main Outcomes and Measures:The primary outcome was change in mean visual acuity letter score at 24 weeks as measured by the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS). The principal secondary outcome was change in mean central subfield thickness as measured with the use of optical coherence tomography.Results:Of the 116 randomized patients, median age was 65 years (interquartile range [IQR], 58-71 years); 50.9% were female and 60.3% were white. Mean (SD) improvement in visual acuity from randomization was 2.7 (9.8) letters in the combination group and 3.0 (7.1) letters in the ranibizumab group, with the adjusted treatment group difference (combination minus ranibizumab) of -0.5 letters (95% CI, -3.6 to 2.5; 2-sided P = .73). Mean (SD) change in central subfield thickness in the combination group was -110 (86) μm compared with -62 (97) μm for the ranibizumab group (adjusted difference, -52; 95% CI, -82 to -22; 2-sided P < .001). Nineteen eyes (29%) in the combination group experienced increased intraocular pressure or initiated treatment with antihypertensive eyedrops compared with 0 in the ranibizumab group (2-sided P < .001).Conclusions and Relevance:Although its use is more likely to reduce retinal thickness and increase intraocular pressure, the addition of intravitreous dexamethasone to continued ranibizumab therapy does not improve visual acuity at 24 weeks more than continued ranibizumab therapy alone among eyes with persistent DME following anti-VEGF therapy.