# Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus

> **NIH NIH U10** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $1,985,974

## Abstract

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.

## Key facts

- **NIH application ID:** 10004043
- **Project number:** 5U10EY026869-05
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** ELISABETH J COHEN
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,985,974
- **Award type:** 5
- **Project period:** 2016-09-30 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004043

## Citation

> US National Institutes of Health, RePORTER application 10004043, Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus (5U10EY026869-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10004043. Licensed CC0.

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