HERPES EYE DISEASE

疱疹性眼病

• 批准号: 2605202
• 负责人: KIRK R WILHELMUS
• 金额: $ 7.62万
• 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 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2605202
• 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.

申请人是当前疱疹性眼病研究的参与者 （BEDS），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 临床试验和疱疹性眼病复发因素的研究。 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基质角膜炎或虹膜炎 患有疱疹性角膜上皮炎 第二个，HEDS-APT，将 比较阿昔洛韦与安慰剂延长复发时间 疱疹性眼病患者的任何疱疹性眼睛发作 在过去一年中，谁没有疾病， 上个月的治疗。 复发因素研究（HEDS-RFS） 将通过问卷调查获得关于压力、创伤和其他潜在的 疱疹性疾病复发的诱因与 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5个 其他参与APT和EKT试验的当地研究中心;以及 通过参与《2010年世界卫生组织 执行委员会。