REGIONAL CENTER--HERPETIC EYE DISEASE STUDY, PHASE II

申请人，当前疱疹性眼病研究的参与者 (HEDS)，提议成为带状疱疹眼病第二阶段的区域中心 疾病研究。 第二阶段将包括两项随机、双盲试验 复发触发因素的临床试验和非实验研究 眼部疱疹病。 第一项试验 HEDS-EKT 将比较阿昔洛韦和安慰剂的疗效 预防或延迟患者随后的角膜炎或虹膜炎 活动性疱疹性上皮性角膜炎。 第二个，HEDS-APT，将比较 阿昔洛韦与安慰剂相比可延长眼部疱疹复发时间 过去曾患过任何疱疹性眼病的患者的疾病 年以及过去没有疾病且停止接受所有治疗的人 月。 触发因素研究将通过压力问卷获得数据， 压力、创伤和其他潜在的复发或疱疹诱因 疾病与两项临床试验的复发数据的相关性。 作为区域中心，申请人将负责进入 两项临床试验中的患者、治疗和随访 根据协议；将同意的随机患者纳入 触发研究；协调并监督9人的参与 其他参与 APT 和 EKT 试验的当地站点；和 通过参与执行委员会参与 HEDS 的治理 委员会。

The applicant, a participant in the current Herpetic Eye Disease Study (HEDS), proposes to be a Regional Center for Phase II of the Herpetic Eye Disease Study. Phase II will consist of two randomized, double-masked clinical trials and a nonexperimental study of triggers of recurrence of ocular herpetic disease. The first trial, HEDS-EKT, will compare acyclovir to placebo for the prevention or delay of subsequent keratitis or iritis in patients with active herpetic epithelial keratitis. The second, HEDS-APT, will compare acyclovir to placebo for prolonging time to recurrence of herpetic eye disease in patients with an episode of any herpetic eye disease in the past year and who have been free of disease and off all treatment for the past month. The triggers study will obtain data by questionnaire on stress, stress, trauma, and other potential triggers of recurrence or herpetic disease for correlation with recurrence data from the two clinical trials. As a Regional Center, the applicant will be responsible for entering patients in the two clinical trials, and treating and following them according to protocol; entering consenting randomized patients into the triggers study; coordinating and overseeing the participating of 9 additional participating local sites in the APT and EKT trials; and participating in the governance of HEDS via participation on the Executive Committee.