Zoster Eye Disease Study



Status:Recruiting
Conditions:Infectious Disease, Ocular
Therapuetic Areas:Immunology / Infectious Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:August 23, 2017
End Date:December 31, 2020

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Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus

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.

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.

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, rash in the dermatomal
distribution of cranial nerve V1.

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).

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 30 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 rescreened. 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 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.
We found this trial at
60
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Donald Miller, MD
Phone: 603-650-0556
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Priscilla Fowler, MD
Phone: 205-488-0777
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Kenneth R Kenyon, MD
Phone: 617-636-1051
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Melissa Daluvoy, MD
Phone: 919-681-8872
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Sonal Tuli, MD
Phone: 352-373-8787
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Shahzad Mian, MD
Phone: 734-647-8397
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Aurora, Colorado 80045
Principal Investigator: Ronald Wise, MD
Phone: 720-848-2035
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Bala-Cynwyd, Pennsylvania 19004
Principal Investigator: Irving M Raber, MD
Phone: 484-434-2706
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Wuqaas Munir, MD
Phone: 667-214-1161
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, Maryland 21215
Principal Investigator: Laura Green, MD
Phone: 410-601-7643
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Bethesda, Maryland 20817
Principal Investigator: Divya Srikumaran, MD
Phone: 240-482-1108
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Bloomington, Minnesota 55431
Principal Investigator: Sherman Reeves, MD
Phone: 952-567-6111
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Principal Investigator: James Chodosh, MD
Phone: 617-573-6823
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Boston, Massachusetts 02118
Principal Investigator: Hyunjoo Lee, MD
Phone: 617-414-8848
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Canandaigua, New York 14424
Principal Investigator: Holly Hindman, MD
Phone: 585-391-1181
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Joel Sugar, MD
Phone: 312-996-7204
Univ of Illinois A major research university in the heart of one of the world's...
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Cincinnati, Ohio 45242
Principal Investigator: Kavitha Sivaraman, MD
Phone: 513-569-3462
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Cleveland, Indiana 44106
Principal Investigator: Pankaj Gupta, MD
Phone: 216-844-8552
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Pankaj Gupta, MD
Phone: 216-844-8552
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Dallas, Texas 75231
Principal Investigator: Gregory Nettune, MD
Phone: 214-696-5900
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Dallas, Texas 75390
Principal Investigator: James McCulley, MD
Phone: 214-645-2012
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Danville, Pennsylvania 17822
Principal Investigator: Herbert Ingraham, MD
Phone: 570-214-6070
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Delray Beach, Florida 33484
Principal Investigator: Steven I Rosenfeld, MD
Phone: 561-498-8100
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East Setauket, New York 11733
Principal Investigator: Azin Abazari, MD
Phone: 631-444-4090
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Glenview, Illinois 60026
Principal Investigator: Marian Macsai, MD
Phone: 847-657-1750
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Golden Valley, Minnesota 55427
Principal Investigator: John Berestka, MD
Phone: 763-383-4140
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Grand Rapids, Michigan 49546
Principal Investigator: Ann M Renucci, MD
Phone: 616-949-2001
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Great Neck, New York 11021
Principal Investigator: Anne Steiner, MD
Phone: 516-881-7046
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Houston, Texas 77030
Principal Investigator: Alice Matoba, MD
Phone: 713-798-4123
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Indianapolis, Indiana 46260
Principal Investigator: Francis Price, Jr., MD
Phone: 317-814-2996
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Douglas G Katz, MD
Phone: 859-323-5868
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Littleton, Colorado 80120
Principal Investigator: Stephen L Forstot, MD
Phone: 720-709-7533
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Loma Linda, California 92354
Principal Investigator: Frank Huang, MD
Phone: 909-558-2168
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Los Angeles, California 90095
Principal Investigator: Gary N Holland, MD
Phone: 310-825-5440
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Sarah Nehls, MD
Phone: 608-262-6222
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Miami, Florida
Principal Investigator: Guillermo Amescua, MD
Phone: 305-326-6508
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261 James Street
Morristown, New Jersey 07960
Principal Investigator: Marta Lopatynsky, MD
Phone: 973-984-3937
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Nashville, Tennessee 37232
Principal Investigator: Uyen Tran, MD
Phone: 615-936-1639
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Nashville, Tennessee 37203
Principal Investigator: Mark D Ewald, MD
Phone: 615-320-7200
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New Orleans, Louisiana 70112
Principal Investigator: Jayne S Weiss, MD
Phone: 504-568-7634
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462 1st Avenue
New York, New York 10010
Principal Investigator: Ilyse Haberman, MD
Phone: 646-501-9883
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1305 York Avenue
New York, New York 10021
Principal Investigator: Jessica Ciralsky, MD
Phone: 646-962-4118
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New York, New York
Principal Investigator: David Ritterband, MD
Phone: 212-979-4251
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Owings Mills, Maryland 21117
Principal Investigator: Marc A Hinig, MD
Phone: 410-581-1500
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Peabody, Massachusetts 02149
Principal Investigator: Sarkis H Sarkiasian, MD
Phone: 978-538-4412
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840 Walnut Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Kristin Hammersmith, MD
Phone: 215-928-3180
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Steven Orlin, MD
Phone: 215-662-8091
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97239
Principal Investigator: John Clements, MD
Phone: 503-494-0482
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Portland, Oregon 97210
Principal Investigator: Michael Straiko, MD
Phone: 503-413-6937
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Richmond, Virginia 23226
Principal Investigator: Christonpher Estopinal, MD
Phone: 804-287-4219
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Rochester, Minnesota 55905
Principal Investigator: Keith Baratz, MD
Phone: 507-538-8119
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Saint Louis, Missouri 63110
Principal Investigator: Andrew Jing-Wei Huang, MD
Phone: 314-747-5832
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Salt Lake City, Utah 84132
Principal Investigator: Amy Lin, MD
Phone: 801-585-6647
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San Antonio, Texas 78229
Principal Investigator: Charles Reilly, MD
Phone: 210-424-2584
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San Francisco, California 94131
Principal Investigator: John Gonzales, MD
Phone: 979-229-4895
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San Luis Obispo, California 93401
Principal Investigator: Mark D Sherman, MD
Phone: 805-503-1016
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Henry Geggel, MD
Phone: 206-342-6976
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Towson, Maryland 21204
Principal Investigator: Angelique Pillar, MD
Phone: 410-616-9953
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Walnut Creek, California 94598
Principal Investigator: Mira Lim, MD
Phone: 925-947-0888
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Washington, District of Columbia 20007
Principal Investigator: Aruoriwo Oboh-Weilke, MD
Phone: 202-444-7237
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