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: 3559971
• 负责人: ELISABETH J COHEN
• 金额: $ 9.57万
• 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/3559971
• 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.

申请人是目前疱疹性眼病研究的参与者 （HEDS），拟成为疱疹眼II期的区域中心 疾病研究。 II期将包括两个随机、双盲 临床试验和非实验性研究的触发复发 眼部疱疹性疾病 第一个试验，HEDS-EKT，将比较阿昔洛韦和安慰剂， 预防或延迟患者的后续角膜炎或虹膜炎， 活动性疱疹性角膜上皮炎。 第二个，HEDS-APT，将比较 阿昔洛韦与安慰剂相比延长疱疹性眼复发时间 过去曾发作过任何疱疹性眼病的患者 过去一年中没有患病和停止所有治疗的人 月 触发因素研究将通过压力问卷获得数据， 压力、创伤和其他复发或疱疹的潜在诱因 疾病与两项临床试验复发数据的相关性。 作为区域中心，申请人将负责进入 两项临床试验中的患者， 根据方案;将知情同意的随机化患者入组 触发因素研究;协调和监督9个 其他参与APT和EKT试验的当地研究中心;以及 通过参与行政管理，参与HEDS的治理 以马克思