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 and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment

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. Ability 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. Ability to understand, and willingness and ability to read and sign, the informed consent form
    6. Diagnosed with HZO in one eye as per the protocol
    7. For Females with reproductive potential should be willing to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence)

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:
      • Subjects 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
      • Subjects diagnosed with Acquired Immune Deficiency Syndrome (AIDS) or presents with other clinical manifestations of Human Immunodeficiency virus (HIV)
      • Subjects who are on immunosuppressive therapy
      • Subjects with unspecified cellular immunodeficiency
      • Subjects with history of hematopoietic stem cell transplantation.
    2. Medical history of a systemic disease and though likely to meet one of the exclusion criteria listed in exclusion #1 during the 18-month study period.
    3. Renal insufficiency
    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, including acyclovir, valacyclovir, or famciclovir, for any reason except for treatment of acute HZO, including investigational drug trial
    8. History of another condition that may require treatment with one of these three antivirals listed above in exclusion criterion #7, during the course of the study; study participants who require chronic suppressive antiviral treatment with these medications will be excluded.
    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. Study participants who meet this criterion may be rescreened.

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