REGIONAL CENTER--HERPETIC EYE DISEASE STUDY, PHASE II

区域中心--疱疹性眼病研究，第二阶段

• 批准号: 3559970
• 负责人: ELISABETH J COHEN
• 金额: $ 9.54万
• 依托单位: WILLS EYE HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-01 至 1997-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559970
• 关键词: acyclovir; clinical trials; community; disease /disorder prevention /control; drug screening /evaluation; eye disorder chemotherapy; human subject; human therapy evaluation; iritis; keratitis; medical complication; ocular herpes; questionnaires; relapse /recurrence; stress; trauma

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.

申请人是当前疱疹眼病研究的参与者 (HEDS)，建议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随机的、双掩蔽的 食道癌复发诱因的临床试验和非实验研究 眼部疱疹。 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角膜炎或虹膜炎 活动性疱疹上皮性角膜炎。第二个，heds-apt，将进行比较 阿昔洛韦与安慰剂联用延长疱疹眼部复发时间 过去有过任何疱疹眼病发作的患者的疾病 在过去的一年里，他们没有患病并停止了所有的治疗 月份。触发者研究将通过问卷调查获得关于压力的数据， 压力、创伤和其他潜在的复发或疱疹诱因 疾病与两个临床试验的复发数据的相关性。 作为区域中心，申请者将负责进入 两个临床试验中的患者，以及治疗和随访 根据协议；将同意的随机患者输入 触发学习；协调和监督9个项目的参与 在APT和EKT试验中增加参与的本地站点；以及 通过对高管的参与参与HEDS的治理 委员会审议阶段。