# Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus

> **NIH NIH U10** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $1,424,768

## Abstract

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.

## Key facts

- **NIH application ID:** 10178985
- **Project number:** 3U10EY026869-05S1
- **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:** $1,424,768
- **Award type:** 3
- **Project period:** 2016-09-30 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10178985

## Citation

> US National Institutes of Health, RePORTER application 10178985, Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus (3U10EY026869-05S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10178985. Licensed CC0.

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