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Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment

Primary Objective

To assess the primary objectives, study participants will be monitored at each visit for new or worsening of any of the following conditions 1. Dendriform epithelial keratitis 2. Stromal keratitis a. Without ulceration b. With ulceration 3. Endothelial keratitis 4. Iritis

Study category: Eyes

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Description

This study is looking to see if treatment with 12 months of daily valacyclovir medication reduces the development of certain types of new or worsening eye disease; specifically, infection on the surface of the front of the eye (cornea), inflammation of the cornea, or inflammation inside the front of the eye. We also hope to find out if this treatment reduces ongoing pain after the shingles infection goes away. In addition, we want to find out if the effects of valacyclovir treatment last during the six months after treatment is finished.

Main Procedures Involved: Safety blood draw at screening, and standard of care Ophthalmic examination at each visit.

Duration of Participation: Study participants will be followed every 3 months for a total of 18 months, 6 months following completion of the 12-month treatment period.

Details
Age

Eligibility

Patient must be diagnosed with shingles in one eye (Herpes Zoster Ophthalmicus), be willing to comply with all study procedures and take oral medication, and to adhere to study medication regimen. If you are immunocompromised or have a history of certain medical conditions, this might exclude you from participation in this study.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Ronald Wise,  MD

Ronald Wise, MD

Study ID

Protocol Number: 17-0585

More information available at ClinicalTrials.gov: NCT03134196

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