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.

申请人是目前疱疹性眼病研究的参与者 （HEDS），建议成为疱疹眼二期的区域中心 疾病研究。 II期将包括两个前瞻性随机， 双盲临床试验和一项关于 眼部疱疹复发。 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的效果 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， 至少在过去的一个月里。 触发研究 （复发因素研究）将通过问卷调查获得有关压力的数据， 创伤和其他疱疹复发的潜在诱因 与两项临床试验的复发日期相关。 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纳入RFS研究; 协调和监督另外8名 参与APT和EKT试验以及RFS研究的当地研究中心; 并通过参与 执行委员会。