HERPES EYE DISEASE

申请人，目前疱疹性眼病的主要中心 研究（HEDS），拟成为牵头中心和区域中心， HEDS第二阶段。II期将包括两个随机、双盲 临床试验和非实验性研究的触发因素 眼部疱疹性疾病复发。 HEDS小组现在建议评估口服阿昔洛韦对 预防疱疹性角膜基质炎和虹膜睫状体炎， 抑制复发。 一项新的HEDS方案将评估口服 在急性疱疹性角膜上皮炎期间给予阿昔洛韦， 预防角膜基质炎和虹膜睫状体炎（疱疹性眼病 研究-上皮性角膜炎试验：HEDS-EKT）。 第二个协议将 评价口服阿昔洛韦预防复发的疗效 疱疹性眼病（疱疹性眼病研究- 阿昔洛韦预防试验- HEDS-APT）。 第三项生物学和 疱疹性眼病复发的心理危险因素 （疱疹性眼病-风险因素研究：HEDS RFS）将确定 在两项临床试验中，这些因素在患者中的重要性。 这些研究将采用基于社区的临床试验设计， 包括8个区域中心，每个中心有5至11个参与站点。 牵头中心将制定和实施培训方案， 区域和参与中心，认证和监督区域 中心，作为执行中心，并参与整个 通过参与所有的HEDS委员会来管理HEDS。 作为区域中心，申请人将在两个 根据方案进行临床试验，并将随机入组患者 触发器的研究 它将协调和监督 另外11个参与APT的本地研究中心参与， EKT试验。

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.