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：
10178985
负责人：
ELISABETH J COHEN
金额：
$ 142.48万
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 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10178985
关键词：
18 year old Adjuvant Affect Aftercare Anterior Antiviral Agents Attenuated Live Virus Vaccine Attenuated Vaccines Behavior COVID-19 COVID-19 pandemic Canada Caring Chickenpox Child Chronic Clinical Communicable Diseases Coronavirus Diagnosis Disease Dose Endothelium Enrollment Epithelial Epithelium Eye Eye diseases Herpes Zoster Ophthalmicus Herpes zoster disease Hospitalization Immunocompetent Infection Insurance Coverage Intubation Keratitis Life Location Masks Measures Natural History Natural Immunity Oral Outcome Outcome Study Pain Participant Patients Placebos Postherpetic neuralgia Poxviridae Quality of life Randomized Randomized Clinical Trials Recombinants Recurrence Reporting Severities Societies Syndrome Testing Time Uveitis Vaccination Vaccines Vision Zoster Vaccine adaptive immunity burden of illness chronic pain cost demographics follow-up health care service utilization immunogenic improved improved outcome infection risk novel older patient primary endpoint secondary endpoint valacyclovir

项目摘要

PROJECT SUMMARY: 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 demographics of HZ and HZO are similar in Canada and the US, with the exception that vaccination against zoster has substantially less insurance coverage and usage in Canada. 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.

项目概要：带状疱疹眼病研究 (ZEDS) 的目的是确定是否长期使用伐昔洛韦进行抑制性口服抗病毒治疗可减少带状疱疹并发症眼科（HZO），从而改善这种常见且潜在的视力的临床结果- 和危及生命的疾病。每年有 1,000,000 例新发带状疱疹 (HZ) 病例美国，10-20%是HZO。 HZ 和 HZO 在加拿大的人口统计数据相似美国，但带状疱疹疫苗的保险金额要少得多加拿大的覆盖范围和使用情况。这种双重掩蔽、安慰剂对照的第一个目标多中心随机临床试验将检验抑制性抗病毒治疗的假设每日口服伐昔洛韦 1000 毫克，连续 12 个月可降低新发或恶化的发生率树状上皮性角膜炎、基质性角膜炎、内皮性角膜炎或葡萄膜炎安慰剂，在 12 个月时作为主要终点，在 18 个月时（包括 6 个月的随访）治疗后，作为次要终点，对于曾有过一次发作的 HZO 患者入组前一年内出现这些疾病表现之一。第二个目标是检验以下假设：口服伐昔洛韦 1000 mg 进行 12 个月的抑制治疗与安慰剂相比，每天服用可减少带状疱疹后神经痛（PHN）的严重程度和持续时间，在类似的 HZO 患者中，以 12 个月和 18 个月作为次要终点。 PHN 是一个使人衰弱的慢性疼痛综合症，对生活质量产生负面影响，尤其是老年人患者。该研究将招募年龄在 18 岁及以上且免疫功能正常的患者过去在不同时间诊断出 HZO，这些类型的活动性眼前节眼病过去一年内的分段疾病。符合条件的患者将按 1:1 的比例随机分配接受口服长期抑制治疗每天服用伐昔洛韦 1000 毫克或安慰剂，持续 12 个月，加上常规眼科护理，然后进行随访每 3 个月一次，总共 18 个月，以确定新的或恶化的树状体的结果上皮性角膜炎、基质性角膜炎、内皮性角膜炎或葡萄膜炎和/或严重程度和持续时间治疗 12 个月期间和治疗停止后 6 个月内出现 PHN。这有关 PHN 的结果可能适用于其他地点的 HZ。如果压抑伐昔洛韦治疗被确定是有效的，可能会带来毁灭性的疾病负担患者的 HZO 和 HZ 的费用以及社会每年的费用可能会减少，估计为美国将达到十亿美元。