Zoster Eye Disease Study (ZEDS)
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|ClinicalTrials.gov Identifier: NCT03134196|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster Ophthalmicus||Drug: Masked Placebo Drug: Masked Oral Valacyclovir||Phase 4|
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.
Primary Aim: The primary 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 iritis compared to placebo, at 12 months as the primary endpoint, and at 18 months including 6 months of follow-up after treatment, as a secondary endpoint, in patients with HZO who have had an episode of one of these disease manifestations during the year prior to enrollment.
Secondary AIM: 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 iritis 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus|
|Actual Study Start Date :||August 23, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Placebo Comparator: Placebo
Encapsulated masked placebo
Drug: Masked Placebo
Active Comparator: Masked Oral Valacyclovir 1000 mg daily
Valacyclovir, 500 mg, oral pill, two 500mg pills daily
Drug: Masked Oral Valacyclovir
Oral Valacyclovir 1000 mg/day
Other Name: Valtrex
- Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis [ Time Frame: 12 months ]The primary outcome measure is time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis,OR Iritis, associated with pre-specified definitions of these disease manifestations and associated treatment requirements, in study participants assigned to valacyclovir compared to placebo, during one year of study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134196
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|Study Chair:||Elisabeth Cohen, MD||NYU Langone Health|