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:9358729
- 负责人:
- 金额:$ 284.91万
- 依托单位:
- 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:
- 关键词:18 year oldAcuteAcyclovirAdultAffectAftercareAgeAnatomyAnteriorAntiviral AgentsAntiviral TherapyCaringChickenpoxChronicClinicalConsensusCorneaCost of IllnessDataData AnalysesDiagnosisDiseaseDoseElderlyEligibility DeterminationEnrollmentEnsureEpithelialExanthemaEyeEye diseasesFamciclovirHerpes Zoster OphthalmicusHerpes zoster diseaseHerpesviridaeHerpesvirus Type 3HourImmunocompetentImpairmentIncidenceInformation DisseminationKeratitisLeadershipLifeLocationMasksMeasuresOralOutcomePainPathogenesisPatientsPlacebo ControlPlacebosPostherpetic neuralgiaPoxviridaePrevention trialProtocols documentationPublicationsQuality of lifeRandomizedRandomized Clinical TrialsRandomized Controlled Clinical TrialsRecording of previous eventsRecurrenceResearch PersonnelSeveritiesSimplexvirusSocietiesSpecific qualifier valueSyndromeTestingTimeUveitisVirus DiseasesVisionWithholding TreatmentWorkburden of illnesschronic paincostefficacy studyfollow-upimprovedimproved outcomeocular painolder patientorganizational structurepreventprospectiverandomized placebo controlled trialtreatment effectvalacyclovir
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)的目的是确定长期的口服抑制性
项目成果
期刊论文数量(0)
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会议论文数量(0)
专利数量(0)
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ELISABETH J COHEN其他文献
ELISABETH J COHEN的其他文献
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{{ truncateString('ELISABETH J COHEN', 18)}}的其他基金
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:
10772633 - 财政年份:2016
- 资助金额:
$ 284.91万 - 项目类别:
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 - 财政年份:2016
- 资助金额:
$ 284.91万 - 项目类别:
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 - 财政年份:2016
- 资助金额:
$ 284.91万 - 项目类别:
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:
9752554 - 财政年份:2016
- 资助金额:
$ 284.91万 - 项目类别:
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:
10178985 - 财政年份:2016
- 资助金额:
$ 284.91万 - 项目类别:
REGIONAL CENTER--HERPETIC EYE DISEASE STUDY, PHASE II
区域中心--疱疹性眼病研究,第二阶段
- 批准号:
3559971 - 财政年份:1992
- 资助金额:
$ 284.91万 - 项目类别:
REGIONAL CENTER--HERPETIC EYE DISEASE STUDY, PHASE II
区域中心--疱疹性眼病研究,第二阶段
- 批准号:
3559970 - 财政年份:1992
- 资助金额:
$ 284.91万 - 项目类别:
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