Zoster Eye Disease Study (ZEDS): A multi-center randomized double-masked placebocontrolled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis stromal ker

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Herpes Zoster Ophthalmicus
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion 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. Diagnosed with Herpes Zoster Ophthalmicus (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
    6. For females with reproductive potential, willingness to use highly effective contraception

You may not be eligible for this study if the following are true:

    1. History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster :
      • Study participants who are diagnosed with leukemia, lymphomas or other malignant neoplasms affecting bone marrow or lymphatic system, unless leukemia in remission and off chemotherapy for at least 3 months
      • Study participants who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS) or presents with other clinical manifestations of Human Immunodeficiency virus (HIV) including CD4 count of = 200 cells/ml
      • Study participants on immunosuppressive therapy including:
        • High-dose corticosteroids (greater than equivalent of prednisone 20 mg/day within 1 month)
        • Chemotherapy, other than low dose used for treatment of immune-mediated diseases within 3 months
        • Study participants receiving recombinant human immune mediators and immune modulators, especially antitumor necrosis agents, within 1 month prior to enrollment
      • Study participants with unspecified cellular immunodeficiency
      • Study participants with history of hematopoietic stem cell transplantation
    2. Medical history of a systemic disease
    3. Renal insufficiency requiring dialysis or has history of renal transplant or eGFR less than 45, determined within 3 months preceding enrollment
    4. Allergy or adverse reaction to valacyclovir or acyclovir
    5. History of vaccination against zoster within one month prior to enrollment
    6. 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
    7. On systemic antivirals with activity against herpes within the past 30 days
    8. History of another condition that may require treatment with antivirals during the course of the study; study participants who require chronic suppressive antiviral treatment
    9. Sexually active women who are pregnant, nursing, or in their reproductive years who do not agree to use contraception during the 1-year treatment period
    10. Incarceration
    11. Any condition or circumstance that in the opinion of the study investigator, would place the study participant in increased risk or affect his/her full compliance or completion of the study
    12. Participation in a clinical study testing a drug, biologic, device or other intervention within the last 30 days from enrollment visit. The study participants who meet this criterion may be rescreened

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.