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CompletedNCT03134196ZEDSUpdated Mar 7, 2025Results posted

Zoster Eye Disease Study

A Phase 4 interventional study of Masked Placebo and Masked Oral Valacyclovir in Herpes Zoster Ophthalmicus, sponsored by NYU Langone Health. Completed at 78 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
527
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

The objective of the Zoster Eye Disease Study (ZEDS) is to determine whether prolonged suppressive oral antiviral treatment with valacyclovir reduces complications of Herpes Zoster Ophthalmicus (HZO), thereby improving clinical outcomes in this common and potentially vision- and life-threatening disease. There are 1,000,000 new cases of Herpes Zoster (HZ) per year in the USA, with 10-20% being HZO.

Specific Aims

Primary Aim: The primary aim of this double-masked, placebo controlled multicenter randomized clinical trial will test the hypothesis that suppressive antiviral treatment for 12 months with oral valacyclovir 1000 mg daily reduces the rate of new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis or iritis compared to placebo, at 12 months as the primary endpoint, and at 18 months including 6 months of follow-up after treatment, as a secondary endpoint, in patients with HZO who have had an episode of one of these disease manifestations during the year prior to enrollment.

Secondary Aim: The second aim is to test the hypothesis that suppressive treatment for 12 months with oral valacyclovir 1000 mg daily reduces the severity and duration of postherpetic neuralgia (PHN), compared to placebo, at 12 months and at 18 months as secondary endpoints, in similar patients with HZO. PHN is a debilitating chronic pain syndrome that negatively impacts quality of life, especially in elderly patients.

The study will enroll immunocompetent patients age 18 years and older who have HZO diagnosed at variable times in the past, with these types of active anterior segment ocular segment disease within the past year. Eligible patients will be randomized in a 1:1 ratio to long-term suppressive treatment with oral valacyclovir 1000 mg daily or placebo for 12 months, plus usual ophthalmic care, and followed every 3 months for a total of 18 months, to determine outcomes of new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis or iritis and/or severity and duration of PHN during 12 months of treatment and for 6 months following treatment discontinuation. The results with regard to PHN may be applicable to HZ in other locations. If suppressive valacyclovir treatment is determined to be effective, the potentially devastating disease burden of HZO and HZ may be reduced for patients, as well as the annual costs to society, estimated in the USA to be one billion dollars.

02

Conditions studied

  • Herpes Zoster Ophthalmicus

Keywords

  • Herpes Zoster Ophthalmicus
  • Zoster Eye Disease Study
  • Varicella Zoster Virus
  • Zoster
  • Shingles
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

PARTICIPANT INCLUSION CRITERIA

To be eligible for study participation, an individual must meet all of the following 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. Age 18 years or older.

  6. Diagnosed with HZO in one eye based on both of these criteria:

    1. History of characteristic unilateral, usually vesicular, HZO rash in the dermatomal distribution of cranial nerve V1 or V2.
    2. 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.

  7. 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:

  1. History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster (44).

    1. 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.
    2. 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.
    3. 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.

  2. 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.

  3. Renal insufficiency:

    1. Requires dialysis or has history of renal transplant or
    2. eGFR less than 45, determined within 3 months days preceding enrollment.
  4. Allergy or adverse reaction to valacyclovir or acyclovir.
  5. 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.
  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 recent onset 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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
527 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Encapsulated masked placebo

    Drug: Masked Placebo

  • Active comparator
    Masked Oral Valacyclovir 1000 mg daily

    Valacyclovir, 500 mg, oral pill, two 500mg pills daily

    Drug: Masked Oral Valacyclovir

Interventions

  • DrugMasked Placebo

    Oral Placebo

  • DrugMasked Oral Valacyclovir

    Oral Valacyclovir 1000 mg/day

    Also known as: Valtrex

05

What researchers measure

Primary outcomes

  1. Number of Participants With the First Occurrence of New or Worsening Stromal Keratitis Without Ulceration (SK), Endothelial Keratitis (EK), Iritis (IR), Dendriform Epithelial Keratitis (DEK), or Stromal Keratitis With Ulceration (SKU)

    The number of participants with the first confirmed endpoint (new or worsening SK, EK, IR, DEK or SKU associated with pre-specified definitions of these disease manifestations and associated treatment requirements within 12 months in study participants assigned to valacyclovir compared to placebo. Diagnostic criteria were defined using the classification for SK, EK, SKU, and DEK caused by Herpes Simplex Virus (HSV) and standardization of uveitis nomenclature (SUN) for IR. A substantial increase in topical steroid treatment, defined as starting, shifting from a lower to higher potency steroid, or doubling frequency of steroid at one visit (new) or gradually within 3 months (worsening) was required for SK, EK, IR, and SKU.

    Time frame: Month 12

Secondary outcomes

  1. Number of Participants With Persistent Treatment Benefit at 18 Months, 6 Months After Cessation of Treatment

    A secondary endpoint, at 18 months, assessed whether the treatment effect persisted 6 months after treatment. Diagnostic criteria were defined using the classification for SK, EK, SKU, and DEK caused by HSV and standardization of uveitis nomenclature (SUN) for IR. A substantial increase in topical steroid treatment, defined as starting, shifting from a lower to higher potency steroid, or doubling frequency of steroid at one visit (new) or gradually within 3 months (worsening) was required for SK, EK, IR, and SKU.

    Time frame: Month 18 (6 months post treatment)

  2. Number of Postherpetic Neuralgia (PHN) Episodes

    PHN was defined by a Zoster Brief Pain Inventory (ZBPI) score of ≥ 3 (the level at which pain interferes with normal activities), persisting, occurring, or reoccurring 3 or more months after the onset of Herpes Zoster Ophthalmicus (HZO).

    Time frame: Month 12

  3. Number of Postherpetic Neuralgia (PHN) Episodes

    PHN was defined by a ZBPI score of ≥ 3 (the level at which pain interferes with normal activities), persisting, occurring, or reoccurring 3 or more months after the onset of HZO

    Time frame: Month 18 (6 months post treatment)

  4. Average Duration of Postherpetic Neuralgia (PHN) Pain

    The duration of pain after zoster is obtained at every visit when they reported pain. Outcome measure was obtained using the Zoster Brief Pain Inventory (ZBPI) score of worst pain in last 24 hours of 3/10 (the level at which pain interferes with normal activities) or more occurring 3 or more months after HZO onset was used to determine the prevalence, severity and duration of PHN.

    Time frame: Month 24 (12 months post-treatment)

  5. Average Duration of Postherpetic Neuralgia (PHN) Pain

    The duration of pain after zoster is obtained at every visit when they reported pain. Outcome measure was obtained using the Zoster Brief Pain Inventory (ZBPI) score of worst pain in last 24 hours of 3/10 (the level at which pain interferes with normal activities) or more occurring 3 or more months after HZO onset was used to determine the prevalence, severity and duration of PHN.

    Time frame: Month 30 (18 months post treatment)

06

Results

Posted Mar 7, 2025

Participant flow

Participant flow — Overall Study
MilestonePlaceboMasked Oral Valacyclovir 1000 mg Daily
Started261266
Completed223237
Not completed3829
Withdrew: Death21
Withdrew: Lost to follow-up1315
Withdrew: Physician decision01
Withdrew: Withdrawal by subject1912
Withdrew: Site unable to contact participant20
Withdrew: Site closed scheduling conflict10
Withdrew: Scheduling conflict10

Outcome measures

PrimaryNumber of Participants With the First Occurrence of New or Worsening Stromal Keratitis Without Ulceration (SK), Endothelial Keratitis (EK), Iritis (IR), Dendriform Epithelial Keratitis (DEK), or Stromal Keratitis With Ulceration (SKU)

The number of participants with the first confirmed endpoint (new or worsening SK, EK, IR, DEK or SKU associated with pre-specified definitions of these disease manifestations and associated treatment requirements within 12 months in study participants assigned to valacyclovir compared to placebo. Diagnostic criteria were defined using the classification for SK, EK, SKU, and DEK caused by Herpes Simplex Virus (HSV) and standardization of uveitis nomenclature (SUN) for IR. A substantial increase in topical steroid treatment, defined as starting, shifting from a lower to higher potency steroid, or doubling frequency of steroid at one visit (new) or gradually within 3 months (worsening) was required for SK, EK, IR, and SKU.

Time frame:
Month 12
Reported as:
Count of participants · Participants
Number of Participants With the First Occurrence of New or Worsening Stromal Keratitis Without Ulceration (SK), Endothelial Keratitis (EK), Iritis (IR), Dendriform Epithelial Keratitis (DEK), or Stromal Keratitis With Ulceration (SKU)
ParticipantsPlaceboMasked Oral Valacyclovir 1000 mg Daily
Number of Participants With the First Occurrence of New or Worsening Stromal Keratitis Without Ulceration (SK), Endothelial Keratitis (EK), Iritis (IR), Dendriform Epithelial Keratitis (DEK), or Stromal Keratitis With Ulceration (SKU)8675
Statistical analysis
  • Masked Oral Valacyclovir 1000 mg Daily · Hazard ratio (hr): 0.78 · 95% CI 0.5 to 1.06
SecondaryNumber of Participants With Persistent Treatment Benefit at 18 Months, 6 Months After Cessation of Treatment

A secondary endpoint, at 18 months, assessed whether the treatment effect persisted 6 months after treatment. Diagnostic criteria were defined using the classification for SK, EK, SKU, and DEK caused by HSV and standardization of uveitis nomenclature (SUN) for IR. A substantial increase in topical steroid treatment, defined as starting, shifting from a lower to higher potency steroid, or doubling frequency of steroid at one visit (new) or gradually within 3 months (worsening) was required for SK, EK, IR, and SKU.

Time frame:
Month 18 (6 months post treatment)
Reported as:
Count of participants · Participants
Number of Participants With Persistent Treatment Benefit at 18 Months, 6 Months After Cessation of Treatment
ParticipantsPlaceboMasked Oral Valacyclovir 1000 mg Daily
Number of Participants With Persistent Treatment Benefit at 18 Months, 6 Months After Cessation of Treatment10487
Statistical analysis
  • Masked Oral Valacyclovir 1000 mg Daily · Hazard ratio (hr): 0.74 · 95% CI 0.56 to 0.99
SecondaryNumber of Postherpetic Neuralgia (PHN) Episodes

PHN was defined by a Zoster Brief Pain Inventory (ZBPI) score of ≥ 3 (the level at which pain interferes with normal activities), persisting, occurring, or reoccurring 3 or more months after the onset of Herpes Zoster Ophthalmicus (HZO).

Time frame:
Month 12
Reported as:
Number · Number of PHN episodes
Number of Postherpetic Neuralgia (PHN) Episodes
Number of PHN episodesPlaceboMasked Oral Valacyclovir 1000 mg Daily
Number of Postherpetic Neuralgia (PHN) Episodes2425
SecondaryNumber of Postherpetic Neuralgia (PHN) Episodes

PHN was defined by a ZBPI score of ≥ 3 (the level at which pain interferes with normal activities), persisting, occurring, or reoccurring 3 or more months after the onset of HZO

Time frame:
Month 18 (6 months post treatment)
Reported as:
Number · Number of PHN episodes
Number of Postherpetic Neuralgia (PHN) Episodes
Number of PHN episodesPlaceboMasked Oral Valacyclovir 1000 mg Daily
Number of Postherpetic Neuralgia (PHN) Episodes2016
SecondaryAverage Duration of Postherpetic Neuralgia (PHN) Pain

The duration of pain after zoster is obtained at every visit when they reported pain. Outcome measure was obtained using the Zoster Brief Pain Inventory (ZBPI) score of worst pain in last 24 hours of 3/10 (the level at which pain interferes with normal activities) or more occurring 3 or more months after HZO onset was used to determine the prevalence, severity and duration of PHN.

Time frame:
Month 24 (12 months post-treatment)
Reported as:
Mean · Months
Average Duration of Postherpetic Neuralgia (PHN) Pain
MonthsPlaceboMasked Oral Valacyclovir 1000 mg Daily
Average Duration of Postherpetic Neuralgia (PHN) Pain14.3 (10.8 to 17.8)13.6 (10.7 to 16.4)
SecondaryAverage Duration of Postherpetic Neuralgia (PHN) Pain

The duration of pain after zoster is obtained at every visit when they reported pain. Outcome measure was obtained using the Zoster Brief Pain Inventory (ZBPI) score of worst pain in last 24 hours of 3/10 (the level at which pain interferes with normal activities) or more occurring 3 or more months after HZO onset was used to determine the prevalence, severity and duration of PHN.

Time frame:
Month 30 (18 months post treatment)
Reported as:
Mean · Months
Average Duration of Postherpetic Neuralgia (PHN) Pain
MonthsPlaceboMasked Oral Valacyclovir 1000 mg Daily
Average Duration of Postherpetic Neuralgia (PHN) Pain18.7 (13.6 to 23.7)13.6 (11.6 to 15.6)

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo2/261 (0.8%)18/261 (6.9%)0/261 (0%)
Masked Oral Valacyclovir 1000 mg Daily1/266 (0.4%)19/266 (7.1%)0/266 (0%)
Most frequent serious events
Showing 10 of 45
Most frequent serious events
EventPlaceboMasked Oral Valacyclovir 1000 mg Daily
Chest PainGeneral disorders2/2610/266
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/2610/266
Crohn's FlareGastrointestinal disorders0/2612/266
COVID-19 InfectionRespiratory, thoracic and mediastinal disorders0/2612/266
Tachy-brady SyndromeCardiac disorders1/2610/266
Myocardial InfarctionCardiac disorders1/2610/266
Left Main Coronary Artery DiseaseCardiac disorders1/2610/266
Sepsis with multi-organ failureGeneral disorders1/2610/266
COVID-19 InfectionInfections and infestations1/2611/266
SepsisInfections and infestations1/2610/266

Baseline characteristics

All randomized participants were included in the data analysis, not just participants who completed the study. Data were analyzed by intention-to-treat.

Age, Continuous
Age, Continuous(years)PlaceboMasked Oral Valacyclovir 1000 mg DailyTotal
Median58 (49 to 68)58 (49 to 66)58 (50 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMasked Oral Valacyclovir 1000 mg DailyTotal
Female135131266
Male126135261
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboMasked Oral Valacyclovir 1000 mg DailyTotal
Hispanic or Latino151126
Not Hispanic or Latino246255501
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboMasked Oral Valacyclovir 1000 mg DailyTotal
American Indian or Alaska Native044
Asian131427
Native Hawaiian or Other Pacific Islander101
Black or African American15722
White222235457
More than one race10616
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboMasked Oral Valacyclovir 1000 mg DailyTotal
Canada293463
United States224226450
New Zealand8614
07

Study locations

78 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • Mayo Clinic - Arizona
    Scottsdale, Arizona 85259, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Scripps Clinic
    La Jolla, California 92037, United States
  • Loma Linda University Eye Institute
    Loma Linda, California 92354, United States
  • Jules Stein Eye Clinic - UCLA
    Los Angeles, California 90095, United States
  • Byers Eye Institute at Stanford University
    Palo Alto, California 94303, United States
  • UCSF- Francis I. Proctor Foundation
    San Francisco, California 94131, United States
  • Pacific Eye Surgeons, Inc.
    San Luis Obispo, California 93401, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • Colorado Cornea Consultants P.C.
    Littleton, Colorado 80120, United States
  • Medstar Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • Delray Eye Associates, PA
    Delray Beach, Florida 33484, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Florida Eye Specialists
    Jacksonville, Florida 33204, United States
  • University of Miami - Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
  • Eye Consultants of Atlanta, PC
    Atlanta, Georgia 30339, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • NorthShore University Health System
    Glenview, Illinois 60026, United States
  • Case Western Reserve University
    Cleveland, Indiana 44106, United States
  • Indiana University - Glick Eye Institute
    Indianapolis, Indiana 46202, United States
  • University of Kansas Medical Center
    Prairie Village, Kansas 66208, United States
  • University of Kentucky
    Lexington, Kentucky 40509, United States
  • LSU Health Science Center
    New Orleans, Louisiana 70112, United States
  • Shreveport Eye Clinic
    Shreveport, Louisiana 71106, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
  • The Krieger Eye Institute
    Baltimore, Maryland 21215, United States
  • Wilmer Eye Institute John Hopkins
    Bethesda, Maryland 20817, United States
  • Crossroads Eye Physician
    Owings Mills, Maryland 21117, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts 02114, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Lahey Medical Center
    Peabody, Massachusetts 01960, United States
  • Eye Health Services
    Weymouth, Massachusetts 02189, United States
  • University of Michigan
    Ann Arbor, Michigan 48105, United States
  • Verdier Eye Center
    Grand Rapids, Michigan 49546, United States
  • Northwest Eye Clinic
    Golden Valley, Minnesota 55427, United States
  • Jennifer Burdick
    Minnetonka, Minnesota 55305, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University Opthalmology
    Saint Louis, Missouri 63110, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • EyeCare MD of NJ
    Morristown, New Jersey 07960, United States
  • Albany Stratton VA Medical Center
    Albany, New York 12208, United States
  • Finger Lakes Ophthalmology /The Eye Care Center
    Canandaigua, New York 14424, United States
  • Stony Brook Ophthalmology
    East Setauket, New York 11733, United States
  • Northwell Health
    Great Neck, New York 11021, United States
  • New York Eye and Ear Infirmary
    New York, New York 10003, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • Weill Cornell Ophthalmology
    New York, New York 10021, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • Devers Eye Institute
    Portland, Oregon 97210, United States
  • Casey Eye Institute - Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Vantage Eye Care Center, LLC
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Geisinger Eye Clinic
    Danville, Pennsylvania 17822, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Corneal Associates at Wills Eye Hospital
    Philadelphia, Pennsylvania 19107, United States
  • University of Tennessee - Hamilton Eye Institute
    Memphis, Tennessee 38163, United States
  • Cornea and Cataract Consultants of Nashville
    Nashville, Tennessee 37203, United States
  • Vanderbilt Eye Institute
    Nashville, Tennessee 37232, United States
  • Cornea Associates of Texas
    Dallas, Texas 75231, United States
  • University of Texas Southwestern
    Dallas, Texas 75390, United States
  • Cornea Consultants of Texas
    Fort Worth, Texas 76107, United States
  • Alkek Eye Center - Baylor College of Medicine
    Houston, Texas 77030, United States
  • R and R Eye Research, LLC
    San Antonio, Texas 78229, United States
  • University of Utah - Moran Eye Center
    Salt Lake City, Utah 84132, United States
  • Virginia Eye Institute
    Richmond, Virginia 23226, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • NY Eye Surgeons
    Seattle, Washington 98133, United States
  • University of Wisconsin - Madison
    Madison, Wisconsin 53705, United States
  • Royal Alexandra Hospital
    Edmonton, Alberta T5H 3V9, Canada
  • University of British Columbia/Vancouver General Hospital Eye Care Centre
    Vancouver, British Columbia V5Z 3N0, Canada
  • Kingston Health Sciences Centre-HDH Site and Queen's University
    Kingston, Ontario K7L 5G2, Canada
  • Prism Eye Institute
    Oakville, Ontario L6H 0J8, Canada
  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montréal, Quebec H2X 3E4, Canada
  • The Research Institute of the McGill University Health Centre/McGill Academic Eye Centre
    Montréal, Quebec H3A 4S5, Canada
  • Clinique Axe Visuel
    Sherbrooke, Quebec J1H4C7, Canada
08

References and documents

Publications

  • Cohen EJ, Hochman JS, Troxel AB, Colby KA, Jeng BH; ZEDS Trial Research Group. Zoster Eye Disease Study: Rationale and Design. Cornea. 2022 May 1;41(5):562-571. doi: 10.1097/ICO.0000000000002743. PubMed 35090154 ↗

Related links

Study documents

  • Protocol and statistical analysis plan · Mar 25, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03134196
Lead sponsor
NYU Langone Health
Collaborators
National Eye Institute (NEI), National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Apr 28, 2017
Start date
Aug 23, 2017
Primary completion
Dec 31, 2023
Completion
Jul 22, 2024
Results posted
Mar 7, 2025
Last update
Mar 7, 2025

Study contacts

Elisabeth Cohen, MD
study chair · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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