Clinical Trial TitleA multi-center, randomized clinical trial of valacyclovir in subjects with keratitis and/or iritis due to herpes zoster ophthalmicus (HZO)
National Clinical Trial Number:NCT03134196
Daisy Pacelli, MPH, RN
Clinical Trial Protocol Description:
This is 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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are age 18 years or older.
- Have been diagnosed with HZO in one eye based on both of these criteria:
- History of characteristic unilateral, usually vesicular, HZO rash in the dermatomal distribution of cranial nerve V1 or V2.
- 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. They can be on variable dose of steroids, and only need to be off oral and topical antivirals by the enrollment visit.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
Jonathan Rubenstein, MD
Daisy Pacelli, MPH, RN
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612