For Physicians Interested in the Zoster Eye Disease Study
NYU Langone is leading the Zoster Eye Disease Study (ZEDS), a large multicenter clinical trial funded by the National Eye Institute of the National Institutes of Health (NIH). The trial is evaluating suppressive valacyclovir treatment to reduce complications of shingles affecting the eye, also known as herpes zoster ophthalmicus (HZO).
For Referring Physicians
ZEDS presents a unique opportunity for you to help us find out whether long-term antiviral treatment reduces complications of HZO. If you have an affected patient you think may be interested in this research study, please contact the ZEDS Coordinating Center at 1-844-698-ZEDS (1-844-698-9337) or firstname.lastname@example.org.
We are happy to answer any questions you may have and make a referral to one of our participating clinical centers in the United States, Canada, and New Zealand.
Zoster Eye Disease Study Trial Design
Approximately 60 clinical centers in the United States, Canada, and New Zealand are enrolling 780 eligible patients with HZO.
The study is a multicenter, double-masked, placebo-controlled, randomized clinical trial that enrolls immunocompetent study participants 18 years of age and older who have had HZO diagnosed at some point in the past with a typical rash, and have had an episode of active keratitis, iritis, or both within 1 year before enrollment.
Eligible study participants are randomized in a 1:1 ratio to treatment with 1,000 mg oral valacyclovir daily or placebo for 1 year. Follow-up involves visits every 3 months for a total of 18 months. Our aim is to determine the time to occurrence of new or worsening specific types of HZO disease (dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, or iritis) during 12 months of treatment and for 6 months after treatment discontinuation among study participants randomized to valacyclovir, as compared with those receiving placebo.
As a secondary outcome, the incidence, severity, and duration of postherpetic neuralgia, a very debilitating chronic pain condition, are evaluated in study participants randomized to valacyclovir, as compared with those receiving placebo.
Rationale for the Zoster Eye Disease Study Trial
The need for a large-scale trial of long-term antiviral use to reduce complications of HZO is supported by extensive published evidence that active varicella-zoster virus (VZV) infection, whether chronic or recurrent, contributes to complications of herpes zoster including HZO, and that suppressive antiviral treatment is effective in reducing recurrent herpes simplex virus (HSV) eye disease, caused by a different but related herpes virus.
The landmark study of long-term use of oral acyclovir for the prevention of recurrent HSV ocular disease, the Herpetic Eye Disease Study (HEDS) Acyclovir Prevention Trial (APT) demonstrated a 45 percent reduction in recurrent ocular disease over 1 year, and was most beneficial in patients with a history of HSV stromal keratitis. ZEDS is for eye disease caused by VZV and is modeled after the HEDS trial, which determined the current standard of care and improved outcomes for HSV eye disease.
Our study will determine whether suppressive antiviral treatment should become a new evidence-based standard of care to reduce eye complications of HZO.
You can also learn more by reading “Zoster Eye Disease Study: Rationale and Design” published in Cornea in 2022.