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Zoster Eye Disease Study (ZEDS)

Primary Purpose

Herpes Zoster Ophthalmicus

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Masked Placebo
Masked Oral Valacyclovir
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Masked Oral Valacyclovir 1000 mg daily

Arm Description

Encapsulated masked placebo

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

Outcomes

Primary Outcome Measures

Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis
The primary outcome measure is time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis,OR Iritis, associated with pre-specified definitions of these disease manifestations and associated treatment requirements, in study participants assigned to valacyclovir compared to placebo, during one year of study treatment.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2017
Last Updated
January 17, 2023
Sponsor
NYU Langone Health
Collaborators
National Eye Institute (NEI), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03134196
Brief Title
Zoster Eye Disease Study
Acronym
ZEDS
Official Title
Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Eye Institute (NEI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster Ophthalmicus
Keywords
Herpes Zoster Ophthalmicus, Zoster Eye Disease Study, Varicella Zoster Virus, Zoster, Shingles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
652 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Encapsulated masked placebo
Arm Title
Masked Oral Valacyclovir 1000 mg daily
Arm Type
Active Comparator
Arm Description
Valacyclovir, 500 mg, oral pill, two 500mg pills daily
Intervention Type
Drug
Intervention Name(s)
Masked Placebo
Intervention Description
Oral Placebo
Intervention Type
Drug
Intervention Name(s)
Masked Oral Valacyclovir
Other Intervention Name(s)
Valtrex
Intervention Description
Oral Valacyclovir 1000 mg/day
Primary Outcome Measure Information:
Title
Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis
Description
The primary outcome measure is time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis,OR Iritis, associated with pre-specified definitions of these disease manifestations and associated treatment requirements, in study participants assigned to valacyclovir compared to placebo, during one year of study treatment.
Time Frame
12 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35090154
Citation
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.
Results Reference
derived
Links:
URL
http://med.nyu.edu/research/zoster-eye-disease-study/
Description
Study website

Learn more about this trial

Zoster Eye Disease Study

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