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: 9358729
• 负责人: ELISABETH J COHEN
• 金额: $ 284.91万
• 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 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9358729
• 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; Eligibility Determination; Enrollment; Ensure; Epithelial; 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; Placebo Control; 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; cost; efficacy study; follow-up; improved; improved outcome; ocular pain; older patient; organizational structure; prevent; prospective; randomized placebo controlled trial; 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.

带状疱疹眼病研究(ZEDS)的目的是确定长期的抑制性口服 万乃洛韦的抗病毒治疗减少了带状疱疹(HZO)的并发症，从而 改善这种常见且潜在危及视力和生命的疾病的临床结果。确实有 美国每年新增带状疱疹病例1,000,000例，其中10-20%为带状疱疹。这样做的第一个目的是 双掩蔽、安慰剂对照的多中心随机临床试验将检验这一假设 每天口服万乃洛韦1000 mg的抑制性抗病毒治疗12个月可降低新发或新发或 与安慰剂相比，树枝状上皮角膜炎、间质角膜炎、内皮角膜炎或葡萄膜炎恶化， 以12个月为主要终点，18个月为主要终点，包括治疗后6个月的随访 有上述疾病表现之一的HZO患者的次要终点 在入学前一年内。第二个目标是检验这一假设，即对12个人进行抑制治疗 每日口服万乃洛韦1000毫克可降低带状疱疹后遗神经痛(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，12个月和18个月作为次要终点。 PHN是一种使人虚弱的慢性疼痛综合征，对生活质量产生负面影响，特别是对老年患者。 这项研究将纳入18岁及以上被诊断为HZO的免疫能力较强的患者 过去，在过去的一年内，有这些类型的活动性眼前节疾病。 符合条件的患者将以1：1的比例随机与口服万乃洛韦1000进行长期抑制治疗 每日服用mg或安慰剂，为期12个月，外加常规眼科护理，每3个月随访一次，共18次 几个月，以确定新的或恶化的树枝状上皮角膜炎，间质角膜炎， 内皮性角膜炎或葡萄膜炎和/或PHN的严重程度和持续时间在12个月和6个月期间 在停止治疗后几个月。有关PHN的结果可能适用于其他地区的HZ 地点。如果确定抑制性万乃洛韦治疗有效，潜在的破坏性 估计，HZO和HZ的疾病负担可能会减轻患者的疾病负担，以及每年给社会带来的成本 在美国是10亿美元。