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: 3559976
• 负责人: PENNY ASBELL
• 金额: $ 12.03万
• 依托单位: MOUNT SINAI SCHOOL OF MEDICINE OF CUNY
• 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/3559976
• 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 in Phase II of the Herpetic Eye Disease Study. Phase II will consist of two prospective randomized, double-masked clinical trials and a study of the triggers for the recurrence of ocular herpetic 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 the tine 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 at least the past month. The triggers study, RFS (Recurrence Factor Study) will obtain data by questionnaire on stress, trauma, and other potential triggers for recurrence of herpetic disease for correlation with recurrence date from the two clinical trials. As a Regional Center, the applicant will be responsible for entering patients in the two clinical trials, treating and following them according to protocol; entering consenting randomized patients into the RFS study; coordinating and overseeing the participation of 8 additional participating local sites in the APT and EKT trials, and the RFS study; 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 (HEDS)，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前瞻性随机、 双盲临床试验和触发因素研究 眼部疱疹病复发。 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 将阿昔洛韦与安慰剂进行比较，以延长复发的时间 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 至少过去一个月的治疗。 触发因素研究，RFS （复发因素研究）将通过压力问卷获得数据， 创伤和其他导致疱疹疾病复发的潜在诱因 与两项临床试验的复发日期的相关性。 作为区域中心，申请人将负责进入 两项临床试验中的患者，根据他们的治疗和随访 协议；将同意的随机患者纳入 RFS 研究； 协调和监督另外 8 个组织的参与 参与 APT 和 EKT 试验以及 RFS 研究的当地站点； 并通过参与 HEDS 的治理 执行委员会。