Jaeb Center for Health Research, Tampa, FL 33647, USA.
Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10. doi: 10.1016/j.ophtha.2008.06.015. Epub 2008 Jul 26.
To evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).
Multicenter, randomized clinical trial.
Eight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320.
Eyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years.
Visual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety.
At 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively.
Over a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.
评估1毫克和4毫克无防腐剂玻璃体内注射曲安奈德与局部/格栅光凝治疗糖尿病性黄斑水肿（DME）的疗效和安全性。
多中心随机临床试验。
693例患有累及黄斑中心凹、视力为20/40至20/320的DME患者的840只研究眼。
将眼睛随机分为局部/格栅光凝组（n = 330）、1毫克玻璃体内注射曲安奈德组（n = 256）或4毫克玻璃体内注射曲安奈德组（n = 254）。每4个月对持续性或新出现的水肿进行再次治疗。主要结局在2年时进行评估。
采用电子糖尿病视网膜病变早期治疗研究方法测量的视力（主要指标）、光学相干断层扫描测量的视网膜厚度（次要指标）以及安全性。
在4个月时，4毫克曲安奈德组的平均视力优于激光组（P<0.001）和1毫克曲安奈德组（P = 0.001）。到1年时，各组间平均视力无显著差异。在16个月访视时以及直至2年的主要结局访视时，激光组的平均视力优于其他两组（在2年时，激光组与1毫克组比较P = 0.02，激光组与4毫克组比较P = 0.002，1毫克组与4毫克组比较P = 0.49）。视力结局的治疗组差异不能仅归因于白内障形成。光学相干断层扫描结果总体上与视力结果平行。在3个治疗组中，分别有4%、16%和3%的眼睛在任何一次访视时眼压较基线升高10 mmHg或更多，3个治疗组中分别有13%、23%和51%的眼睛接受了白内障手术。
在2年期间，对于大多数具有与本临床试验队列相似特征的DME患者，局部/格栅光凝比1毫克或4毫克无防腐剂玻璃体内注射曲安奈德更有效且副作用更少。本研究结果还支持，在DME的临床试验中，局部/格栅光凝目前应作为与其他治疗方法进行比较的基准。
