HERPETIC EYE DISEASE STUDY - REGIONAL COORD. CENTER

疱疹性眼病研究 - 区域坐标。

• 批准号: 3559979
• 负责人: KIRK R WILHELMUS
• 金额: $ 10.61万
• 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/3559979
• 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，当前疱疹性眼病研究的参与者 (BEDS)，提议成为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 带状疱疹眼病复发因素的临床试验和研究。 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发生基质性角膜炎或虹膜炎 患有活动性疱疹性上皮性角膜炎。 第二个，HEDS-APT，将 比较阿昔洛韦和安慰剂以延长复发时间 任何疱疹性眼病发作患者的疱疹性眼病 过去一年中没有患病以及没有患病且一切正常的人 过去一个月的治疗情况。 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 疱疹病复发的诱因与相关性 两项临床试验的复发数据。 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；协调和监督5人的参与 其他参与 APT 和 EKT 试验的当地站点；和 通过参与 HEDS 的治理 执行委员会。