Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus

长期抑制伐昔洛韦治疗眼部带状疱疹

• 批准号: 10004043
• 负责人: ELISABETH J COHEN
• 金额: $ 198.6万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004043
• 关键词: 18 year old; Acute; Acyclovir; Adult; Affect; Aftercare; Age; Anatomy; Anterior; Antiviral Agents; Antiviral Therapy; Caring; Chickenpox; Chronic; Clinical; Consensus; Cornea; Cost of Illness; Data; Data Analyses; Diagnosis; Disease; Dose; Elderly; Endothelium; Enrollment; Ensure; Epithelial; Epithelium; Exanthema; Eye; Eye diseases; Famciclovir; Herpes Zoster Ophthalmicus; Herpes zoster disease; Herpesviridae; Herpesvirus Type 3; Hour; Immunocompetent; Impairment; Incidence; Information Dissemination; Keratitis; Leadership; Life; Location; Masks; Measures; Oral; Outcome; Pain; Pathogenesis; Patients; Placebos; Postherpetic neuralgia; Poxviridae; Prevention trial; Protocols documentation; Publications; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recording of previous events; Recurrence; Research Personnel; Severities; Simplexvirus; Societies; Specific qualifier value; Syndrome; Testing; Time; Uveitis; Virus Diseases; Vision; Withholding Treatment; Work; burden of illness; chronic pain; clinical center; cost; efficacy study; follow-up; improved; improved outcome; ocular pain; older patient; organizational structure; prevent; primary endpoint; prospective; randomized placebo controlled trial; secondary endpoint; treatment effect; valacyclovir

The objective of the Zoster Eye Disease Study (ZEDS) is to determine whether prolonged suppressive oral antiviral treatment with valacyclovir reduces complications of Herpes Zoster Ophthalmicus (HZO), thereby improving clinical outcomes in this common and potentially vision- and life-threatening disease. There are 1,000,000 new cases of Herpes Zoster (HZ) per year in the USA, with 10-20% being HZO. The first aim of this double-masked, placebo controlled multicenter randomized clinical trial will test the hypothesis that suppressive antiviral treatment for 12 months with oral valacyclovir 1000 mg daily reduces the rate of new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis or uveitis compared to placebo, at 12 months as the primary endpoint, and at 18 months including 6 months of follow-up after treatment, as the secondary endpoint, in patients with HZO who have had an episode of one of these disease manifestations during the year prior to enrollment. The second aim is to test the hypothesis that suppressive treatment for 12 months with oral valacyclovir 1000 mg daily reduces the severity and duration of postherpetic neuralgia (PHN), compared to placebo, at 12 months and at 18 months as secondary endpoints, in similar patients with HZO. PHN is a debilitating chronic pain syndrome that negatively impacts quality of life, especially in elderly patients. The study will enroll immunocompetent patients age 18 years and older who have HZO diagnosed at variable times in the past, with these types of active anterior segment ocular segment disease within the past year. Eligible patients will be randomized in a 1:1 ratio to long-term suppressive treatment with oral valacyclovir 1000 mg daily or placebo for 12 months, plus usual ophthalmic care, and followed every 3 months for a total of 18 months, to determine outcomes of new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis or uveitis and/or severity and duration of PHN during 12 months of treatment and for 6 months following treatment discontinuation. The results with regard to PHN may be applicable to HZ in other locations. If suppressive valacyclovir treatment is determined to be effective, the potentially devastating disease burden of HZO and HZ may be reduced for patients, as well as the annual costs to society, estimated in the USA to be one billion dollars.

带状管眼疾病研究（ZEDS）的目的是确定是否长期抑制口服 Valacyclovir的抗病毒药治疗减少了疱疹带状疱疹的并发症（HZO），从而减少 在这种常见和潜在的视力和威胁生命的疾病中，改善了临床结果。有 在美国，每年有1,000,000例新的疱疹带状疱疹（Hz），其中10-20％为HZO。第一个目的 双掩盖的安慰剂控制的多中心随机临床试验将检验以下假设。 每天用口服Valacyclovir 1000毫克抑制抗病毒治疗12个月可降低新的或 与安慰剂相比 在第12个月作为主要终点，在18个月时，包括治疗后6个月的随访，作为 次要终点，在患有其中一种疾病表现的HZO患者中 在入学前的一年。第二个目的是检验以下假设：12 每天口服Valacyclovir 1000毫克的月份减少了后骨神经痛（PHN）的严重程度和持续时间 与安慰剂相比，在类似的Hzo患者中，在12个月和18个月作为继发终点。 PHN是一种使人衰弱的慢性疼痛综合征，会对生活质量产生负面影响，尤其是在老年患者中。 该研究将注册18岁及以上的免疫能力患者，他们在可变的情况下被诊断出 过去，在过去一年中，这些类型的活跃的前部眼部段疾病。 符合条件的患者将以口服Valacyclovir 1000的长期抑制治疗为1：1随机分配 毫克每日或安慰剂12个月，再加上通常的眼科护理，每3个月遵循每3个月，总计18个月 几个月，为了确定新的或恶化的树突状上皮角膜炎的结局，基质角膜炎， 在治疗12个月内，内皮性角膜炎或葡萄膜炎和/或PHN的严重程度和持续时间，有6个 治疗停药后的几个月。关于PHN的结果可能适用于其他 位置。如果确定抑制性的valacyclovir治疗是有效的，则可能是毁灭性的 据估计 在美国为十亿美元。