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: 10614775
• 负责人: ELISABETH J COHEN
• 金额: $ 67.92万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10614775
• 关键词: 18 year old; Affect; Aftercare; COVID-19; COVID-19 diagnosis; Canada; Caring; Chickenpox; Chronic; Clinical; Diagnosis; Disease; Dose; Endothelium; Enrollment; Epithelial; Eye; Eye diseases; Herpes Zoster Ophthalmicus; Herpes zoster disease; Immunocompetent; Insurance Coverage; Iritis; Keratitis; Life; Location; Masks; Oral; Outcome; Outcome Study; Pain; Patients; Placebo Control; Placebos; Postherpetic neuralgia; Poxviridae; Quality of life; Randomized; Randomized Clinical Trials; Severities; Societies; Syndrome; Testing; Time; Uveitis; Vaccination; Vision; burden of illness; chronic pain; cost; demographics; follow-up; improved; improved outcome; older patient; primary endpoint; secondary endpoint; valacyclovir

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 followup 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. PHN is a debilitating chronic pain syndrome that negatively impacts quality of life, especially in elderly patients. Additional aims are to evaluate the impact of vaccination against zoster on study outcomes and COVID-19, and relationship between COVID- 19 diagnosis and/or vaccination on onset of HZO. The study will enroll immunocompetent patients age 18 years and older who have HZO diagnosed at variable times in the past, with active keratitis and/or iritis 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，在患有 HZO 发作的患者中 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， 12个月和18个月时。 PHN 是一种使人衰弱的慢性疼痛综合征，会对 影响生活质量，尤其是老年患者。其他目标是评估影响 带状疱疹疫苗接种对研究结果和 COVID-19 以及 COVID-19 之间关系的影响 19 HZO 发病时的诊断和/或疫苗接种。 该研究将招募年龄在 18 岁及以上且免疫功能正常的 HZO 患者 过去在不同时间被诊断出，在过去一年内患有活动性角膜炎和/或虹膜炎。 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。