HERPETIC EYE DISEASE STUDY - REGIONAL COORD. CENTER

疱疹性眼病研究 - 区域坐标。

• 批准号: 3559978
• 负责人: KIRK R WILHELMUS
• 金额: $ 10.89万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-20 至 1997-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559978
• 关键词: acyclovir; chemoprevention; clinical trials; combination chemotherapy; disease /disorder proneness /risk; eye agent; eye disorder chemotherapy; eye injury; human subject; human therapy evaluation; iridocyclitis; keratitis; medical complication; ocular herpes; oral administration; physiologic stressor; psychobiology; psychological stressor; questionnaires; relapse /recurrence

The applicant, a participant in the current Herpetic eye Disease Study (BEDS), 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 study of recurrent factors of herpetic eye 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 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 recurrence factors study (HEDS-RFS) will obtain data by questionnaire on stress, trauma, and other potential triggers of recurrence of 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 participation of 5 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 (病床)，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随机的、双掩蔽的 疱疹病毒性眼病的临床试验和复发因素研究。 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肿瘤复发时间方面的比较 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 过去一个月的治疗。复发因素研究(HEDS-RFS) 将通过问卷调查获得有关压力、创伤和其他潜在因素的数据 疱疹病毒病复发的诱因与 两项临床试验的复发数据。 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5人的参与 在APT和EKT试验中增加参与的本地站点；以及 通过参与HED的管理 执行委员会。