Zoster Eye Disease Study (ZEDS)
Herpes Zoster Ophthalmicus
About this trial
This is an interventional treatment trial for Herpes Zoster Ophthalmicus focused on measuring Herpes Zoster Ophthalmicus, Zoster Eye Disease Study, Varicella Zoster Virus, Zoster, Shingles
Eligibility Criteria
PARTICIPANT INCLUSION CRITERIA
To be eligible for study participation, an individual must meet all of the following criteria:
- Ability to understand, and willingness and ability to read and sign, the informed consent form.
- Ability to understand and follow instructions and study procedures.
- Willingness to comply with all study procedures and be available for the duration of the study.
- Ability to take oral medication, and are willing to adhere to study medication regimen.
- Age 18 years or older.
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.
i. 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.
- For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
PARTICIPANT EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster (44).
- 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:
i. High-dose corticosteroids (greater than equivalent of prednisone 20 mg/day within 1 month) ii. Chemotherapy, other than low dose used for treatment of immune-mediated diseases within 3 months iii. Study participants receiving recombinant human immune mediators and immune modulators, especially antitumor necrosis agents, within 1 month prior to enrollment d. Study participants with unspecified cellular immunodeficiency. e. Study participants with history of hematopoietic stem cell transplantation.
- Medical history of a systemic disease and thought likely to meet one of the exclusion criteria listed in exclusion criterion #1 during the 18-month study period.
Renal insufficiency:
- Requires dialysis or has history of renal transplant or
- eGFR less than 45, determined within 3 months days preceding enrollment.
- Allergy or adverse reaction to valacyclovir or acyclovir.
- History of vaccination against zoster within one month prior to enrollment. Study participants who meet this exclusion criterion may be may be screened and enrollment delayed until eligible within 3 months. If the study participant receives the Herpes Zoster Subunit vaccine (Recombinant Zoster Vaccine (RZV), Shingrix), rescreening should take place one month after the second required dose of the vaccine.
- 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.
- On systemic antivirals with activity against herpes within the past 30 days, including acyclovir, valacyclovir, or famciclovir, for any reason except for treatment of recent onset HZO, including investigational drug trial.
- 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.
- 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.
- Incarceration
- 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.
- 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.
Sites / Locations
- University of Alabama at Birmingham
- Mayo Clinic - Arizona
- University of Arkansas for Medical Sciences
- Scripps Clinic
- Loma Linda University Eye Institute
- Jules Stein Eye Clinic - UCLA
- Byers Eye Institute at Stanford University
- UCSF- Francis I. Proctor Foundation
- Pacific Eye Surgeons, Inc.
- University of Colorado
- Colorado Cornea Consultants P.C.
- Medstar Georgetown University Hospital
- Delray Eye Associates, PA
- University of Florida
- Florida Eye Specialists
- University of Miami - Bascom Palmer Eye Institute
- Eye Consultants of Atlanta, PC
- University of Illinois
- NorthShore University Health System
- Case Western Reserve University
- Indiana University - Glick Eye Institute
- University of Kansas Medical Center
- University of Kentucky
- LSU Health Science Center
- Shreveport Eye Clinic
- University of Maryland
- The Krieger Eye Institute
- Wilmer Eye Institute John Hopkins
- Crossroads Eye Physician
- Tufts Medical Center
- Massachusetts Eye and Ear Infirmary
- Boston Medical Center
- Lahey Medical Center
- Eye Health Services
- University of Michigan
- Verdier Eye Center
- Northwest Eye Clinic
- Jennifer Burdick
- Mayo Clinic
- Washington University Opthalmology
- Dartmouth Hitchcock Medical Center
- EyeCare MD of NJ
- Albany Stratton VA Medical Center
- Finger Lakes Ophthalmology /The Eye Care Center
- Stony Brook Ophthalmology
- Northwell Health
- New York Eye and Ear Infirmary
- NYU Langone Health
- Weill Cornell Ophthalmology
- Duke University
- Cincinnati Eye Institute
- Case Western Reserve University
- Devers Eye Institute
- Casey Eye Institute - Oregon Health and Science University
- Vantage Eye Care Center, LLC
- Geisinger Eye Clinic
- University of Pennsylvania
- Corneal Associates at Wills Eye Hospital
- University of Tennessee - Hamilton Eye Institute
- Cornea and Cataract Consultants of Nashville
- Vanderbilt Eye Institute
- Cornea Associates of Texas
- University of Texas Southwestern
- Cornea Consultants of Texas
- Alkek Eye Center - Baylor College of Medicine
- R and R Eye Research, LLC
- University of Utah - Moran Eye Center
- Virginia Eye Institute
- Virginia Mason Medical Center
- NY Eye Surgeons
- University of Wisconsin - Madison
- Royal Alexandra Hospital
- University of British Columbia/Vancouver General Hospital Eye Care Centre
- Kingston Health Sciences Centre-HDH Site and Queen's University
- Prism Eye Institute
- Centre Hospitalier de l'Université de Montréal (CHUM)
- The Research Institute of the McGill University Health Centre/McGill Academic Eye Centre
- Clinique Axe Visuel
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Masked Oral Valacyclovir 1000 mg daily
Encapsulated masked placebo
Valacyclovir, 500 mg, oral pill, two 500mg pills daily