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

基本信息

批准号：
9752554
负责人：
ELISABETH J COHEN
金额：
$ 327.87万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
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/9752554
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 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 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

项目摘要

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) 的目的是确定长期抑制口腔是否使用伐昔洛韦进行抗病毒治疗可减少眼部带状疱疹 (HZO) 的并发症，从而改善这种常见且可能危及视力和生命的疾病的临床结果。有美国每年新增 1,000,000 例带状疱疹 (HZ) 病例，其中 10-20% 为 HZO。本次活动的第一个目的双盲、安慰剂对照多中心随机临床试验将检验以下假设：每日口服伐昔洛韦 1000 毫克，为期 12 个月的抑制性抗病毒治疗可降低新发或与安慰剂相比，树状上皮性角膜炎、基质性角膜炎、内皮性角膜炎或葡萄膜炎恶化， 12 个月作为主要终点，18 个月（包括治疗后 6 个月的随访）作为次要终点，发生过这些疾病表现之一的 HZO 患者入学前一年内。第二个目的是检验以下假设：抑制治疗 12 每天口服伐昔洛韦 1000 毫克几个月可减少带状疱疹后神经痛 (PHN) 的严重程度和持续时间，与安慰剂相比，在 12 个月和 18 个月时作为次要终点，在类似的 HZO 患者中进行。 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，尤其是老年患者。该研究将招募年龄 18 岁及以上、免疫功能正常、在不同时期诊断出 HZO 的患者。过去一年内患有这些类型的活动性眼前节眼部疾病。符合条件的患者将按 1:1 的比例随机分配接受口服伐昔洛韦 1000 的长期抑制治疗每天 1 毫克或安慰剂，持续 12 个月，加上常规眼科护理，每 3 个月随访一次，总共 18 个月几个月，以确定新的或恶化的树状上皮角膜炎、基质角膜炎的结果，治疗 12 个月期间和 6 个月内出现内皮性角膜炎或葡萄膜炎和/或 PHN 的严重程度和持续时间治疗停止后几个月。有关 PHN 的结果可能适用于其他领域的 HZ 地点。如果抑制性伐昔洛韦治疗被确定是有效的，那么潜在的毁灭性后果据估计，HZO 和 HZ 可能会减轻患者的疾病负担以及社会每年的费用在美国是十亿美元。