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.
Protocol Identifying Number: 16-00463
Principal Investigator: Sarah Nehls, MD
Study Coordinator: Kris Dietzman
Funded by: The National Eye Institute
To evaluate whether or not prolonged suppressive oral antiviral treatment with valacyclovir reduces complications of HZO including new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis and/or postherpetic neuralgia compared to placebo.
Phase 3 study
Description of Study Agent:
Valacyclovir: two 500 mg pills daily
Placebo: encapsulated matching placebo
Projected 5 years: approximately 36-month accrual period plus 12 months treatment and 6 months additional follow-up for last enrolled participant, and 6 month close-out and analysis period.
18 months (12 months receiving study medication)
PARTICIPANT INCLUSION CRITERIA
To be eligible for study participation, an individual must meet all of the following criteria:
1. Ability to understand, and willingness and ability to read and sign, the informed consent form.
2. Ability to understand and follow instructions and study procedures.
3. Willingness to comply with all study procedures and be available for the duration of the study.
4. Ability to take oral medication, and are willing to adhere to study medication regimen.
5. Age 18 years or older.
6. Diagnosed with HZO in one eye based on both of these criteria:
History of characteristic unilateral vesicular rash in the dermatomal distribution of cranial nerve V1.
Medical record documentation of an episode of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO within the preceding year. This episode of active anterior segment ocular disease may be due to HZO of recent onset (within the preceding 6 months); or chronic HZO (with onset six or more months ago); may be new, worsening, or recurrent disease after a period of inactivity; and may occur after medication was reduced.
Study participants with chronic HZO must be on a stable treatment regimen and off antivirals for at least 30 days before enrollment. Study participants with chronic HZO who do not meet this criterion may be rescreened, if they are able to meet this criterion within 3 months after the study visit. (This is not a requirement for study participants with recent onset HZO, who may be enrolled at any time, preferably after completing recommended acute antiviral treatment, if prescribed, is completed).
7. For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
For more information, contact Kris Dietzman 608-263-9035