Actively Recruiting // Clinical Trials // Cornea // Sarah Nehls // Feb 07 2018
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 (ZEDS)
Sponsor: New York University Langone Health
Principal Investigator: Sarah Nehls, MD
Study Coordinator: Kris Dietzman
To determine whether prolonged suppressive oral antiviral treatment with valacyclovir reduces complications of Herpes Zoster Ophthalmicus (HZO).
Patients will be randomized in a 1:1 ratio to receive treatment with oral valacyclovir 1000 mg daily or placebo for 12 months. Subjects will be followed every 3 months for a total of 18 months and will continue to receive usual ophthalmic care.
Age 18 years or older
Diagnosed with HZO in one eye based on 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
History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster (44)
Requires dialysis or has history of renal transplant or
eGFR less than 45, determined within 3 months days preceding enrollment
Keratorefractive surgery, other than limbal relaxing incisions or astigmatic keratotomies at the time of cataract surgery, within 5 years of enrollment, or keratoplasty of the involved eye with zoster