Ip Michael S, Bressler Susan B, Antoszyk Andrew N, Flaxel Christina J, Kim Judy E, Friedman Scott M, Qin Haijing
University of Wisconsin Fundus Photograph Reading Center, Madison, WI, USA.
Retina. 2008 Jul-Aug;28(7):919-30. doi: 10.1097/IAE.0b013e31818144a7.
To compare baseline demographic, systemic, and ocular characteristics within age and racial subgroups among participants in this Diabetic Retinopathy Clinical Research Network clinical trial and to compare this cohort with other cohorts enrolled in phase 3 clinical trials for diabetic retinopathy.
Thirty-six month, randomized, controlled, multicenter clinical trial of 693 participants with diabetic macular edema enrolled at 88 clinical sites in the United States. Participants were categorized into self-reported race/ethnicity subgroups and into one of three age groups: 18 to <60, 60 to <70, and 70 and older.
Mean age of participants was 63 years, 72% were white, and median visual acuity letter score was 62 (approximately 20/63). No substantial difference was identified between racial subgroups for any baseline variable. Older participants were more likely to have Type 2 diabetes mellitus and longer duration disease. The most frequent levels of diabetic retinopathy among 840 study eyes were moderate (level 43) to moderately severe (level 47) nonproliferative disease.
While the racial composition of this cohort does not differ from other cohorts in large phase 3 trials that have evaluated participants with diabetic retinopathy, the inclusion of many subjects over age 70 and a better level of glycemic control are distinguishing features.
比较糖尿病视网膜病变临床研究网络这项临床试验参与者中不同年龄和种族亚组的基线人口统计学、全身和眼部特征，并将该队列与其他参与糖尿病视网膜病变3期临床试验的队列进行比较。
对693例糖尿病性黄斑水肿患者进行为期36个月的随机对照多中心临床试验，这些患者在美国88个临床地点入组。参与者被分为自我报告的种族/族裔亚组以及三个年龄组之一：18至<60岁、60至<70岁和70岁及以上。
参与者的平均年龄为63岁，72%为白人，视力字母评分中位数为62（约20/63）。未发现任何基线变量在种族亚组之间存在实质性差异。年龄较大的参与者更有可能患2型糖尿病且病程更长。在840只研究眼中，糖尿病视网膜病变最常见的程度为中度（43级）至中度严重（47级）非增殖性疾病。
虽然该队列的种族构成与其他评估糖尿病视网膜病变参与者的大型3期试验队列没有差异，但纳入了许多70岁以上的受试者以及更好的血糖控制水平是其显著特征。
