REGIONAL CENTER, HERPETIC EYE DISEASE STUDY, PHASE II

申请人是当前疱疹眼病研究的参与者 (HEDS)，计划成为疱疹病毒眼二期的区域中心 疾病研究。第二阶段将包括两个前瞻性随机试验， 双掩蔽临床试验和诱发因素的研究 眼部疱疹复发。 第一个试验，HEDS-EKT，将对阿昔洛韦和安慰剂进行比较 预防或延迟患者继发性间质性角膜炎或虹膜炎 伴有活动性疱疹上皮性角膜炎。第二个，heds-apt，将 阿昔洛韦与安慰剂在延长食道癌复发中的作用比较 任何一只眼疱疹患者的疱疹眼病 在过去的一年里，他们没有得病，也没有感染 至少在过去一个月里接受了治疗。触发器研究，RFS (复发因素研究)将通过问卷调查获得关于压力的数据， 创伤和其他可能导致疱疹复发的诱因 与两个临床试验的复发日期的相关性。 作为区域中心，申请者将负责进入 两个临床试验中的患者，根据治疗和随访 TO方案；将同意的随机患者纳入RFS研究； 协调和监督8个额外成员的参与 参加APT和ECT试验以及RFS研究的地方站点； 以及通过参与HED的 执行委员会。

The applicant, a participant in the current Herpetic Eye Disease Study (HEDS), proposes to be a Regional Center in Phase II of the Herpetic Eye Disease Study. Phase II will consist of two prospective randomized, double-masked clinical trials and a study of the triggers for the recurrence of ocular herpetic disease. The first trial, HEDS-EKT, will compare acyclovir to placebo for the prevention or delay of subsequent stromal keratitis or iritis in patients with active herpetic epithelial keratitis. The second, HEDS-APT, will compare acyclovir to placebo for prolonging the tine 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 at least the past month. The triggers study, RFS (Recurrence Factor Study) will obtain data by questionnaire on stress, trauma, and other potential triggers for recurrence of herpetic disease for correlation with recurrence date from the two clinical trials. As a Regional Center, the applicant will be responsible for entering patients in the two clinical trials, treating and following them according to protocol; entering consenting randomized patients into the RFS study; coordinating and overseeing the participation of 8 additional participating local sites in the APT and EKT trials, and the RFS study; and participating in the governance of HEDS via participation on the Executive Committee.