HERPES EYE DISEASE

疱疹性眼病

• 批准号: 2163377
• 负责人: CHANDLER R DAWSON
• 金额: $ 18.98万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 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/2163377
• 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, the Lead Center in the current Herpetic Eye Diseases Study (HEDS), proposes to be the Lead Center and a Regional Center for Phase II of HEDS. Phase II will consist of two randomized, double-masked clinical trials and a non-experimental study of trigger factors of recurrence of ocular herpetic diseases. The HEDS group now proposes to evaluate oral acyclovir for the prevention of herpetic stromal keratitis and iridocyclitis and the suppression of recurrences. One new HEDS protocol will evaluate oral acyclovir given during acute herpetic epithelial keratitis for preventing stromal keratitis and iridocyclitis (Herpetic Eye Disease Study - Epithelial Keratitis Trial: HEDS-EKT). A second protocol will evaluate the efficacy of oral acyclovir for preventing recurrent episodes of herpetic eye disease (Herpetic Eye Diseases Study - Acyclovir Prevention Trial - HEDS-APT). A third study of biological and psychological risk factors for recurrences of herpetic eye disease (Herpetic Eye Disease - Risk Factor Study: HEDS RFS) will determine the importance of these factors among patients in the two clinical trials. The studies will utilize a community-based clinical trial design and include eight regional centers with five to 11 participating sites each. The Lead Center will develop and carry out training programs for the Regional and Participating Centers, certify and monitor Regional Centers, act as the executive center, and participate in the overall governance of HEDS by participation in all HEDS committees. As a Regional Center, the applicant will enter patients in the two clinical trials according to protocol and will enter randomized patients into the triggers study. It will coordinate and oversee the participation of 11 additional participating local sites in the APT and EKT trials.

申请人，当前疱疹性眼病牵头中心 研究（HEDS），提议成为牵头中心和区域中心 HEDS 第二阶段。第二阶段将包括两项随机、双盲试验 触发因素的临床试验和非实验研究 眼部疱疹性疾病复发。 HEDS 小组现在建议评估口服阿昔洛韦的治疗效果 预防疱疹性基质性角膜炎和虹膜睫状体炎 抑制复发。 一项新的 HEDS 协议将评估口腔 阿昔洛韦治疗急性疱疹性上皮性角膜炎 预防基质性角膜炎和虹膜睫状体炎（疱疹性眼病） 研究 - 上皮性角膜炎试验：HEDS-EKT）。 第二个协议将 评估口服阿昔洛韦预防复发的功效 疱疹性眼病的发作（疱疹性眼病研究 - 阿昔洛韦预防试验 - HEDS-APT）。 第三项生物学研究 带状疱疹性眼病复发的心理危险因素 （疱疹性眼病 - 危险因素研究：HEDS RFS）将确定 这些因素在两项临床试验中对患者的重要性。 这些研究将利用基于社区的临床试验设计和 包括八个区域中心，每个区域中心有 5 到 11 个参与地点。 领导中心将为领导者制定并开展培训计划 区域和参与中心，认证和监控区域 中心，作为执行中心，参与全局 通过参与所有 HEDS 委员会来治理 HEDS。 作为区域中心，申请人将在两个区域输入患者 根据方案进行临床试验并将随机进入患者 进入触发因素研究。 它将协调和监督 另有 11 个参与 APT 的本地站点的参与，以及 EKT 试验。