Zoster Eye Disease Study
- Conditions
- Herpes Zoster Ophthalmicus
- Interventions
- Drug: Masked PlaceboDrug: Masked Oral Valacyclovir
- Registration Number
- NCT03134196
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 652
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Masked Placebo Encapsulated masked placebo Masked Oral Valacyclovir 1000 mg daily Masked Oral Valacyclovir Valacyclovir, 500 mg, oral pill, two 500mg pills daily
- Primary Outcome Measures
Name Time Method Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis 12 months 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
Name Time Method Number of episodes of new or worsening dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis 6 months post treatment Number of Postherpetic Neuralgia (PHN) episodes 6 months post treatment Average duration of Postherpetic Neuralgia (PHN) episodes 6 months post treatment Number of patients who develop specific manifestations of Herpes Zoster Ophthalmicus (HZO) Month 12 Specific manifestations of HZO include as as dendriform epithelial keratitis, stromal keratitis (all types), endothelial keratitis, iritis requiring pre-specified changes in treatment (see MOP), neurotrophic keratopathy with or without melting and/or microbial superinfection, episcleritis, and/or scleritis
Number of patients who develop secondary glaucoma 6 months post treatment Secondary glaucoma determined by Intraocular Pressure and treatment required.
Trial Locations
- Locations (77)
Eye Consultants of Atlanta, PC
🇺🇸Atlanta, Georgia, United States
The Krieger Eye Institute
🇺🇸Baltimore, Maryland, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Alkek Eye Center - Baylor College of Medicine
🇺🇸Houston, Texas, United States
Mayo Clinic - Arizona
🇺🇸Scottsdale, Arizona, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Eye Health Services
🇺🇸Weymouth, Massachusetts, United States
Shreveport Eye Clinic
🇺🇸Shreveport, Louisiana, United States
Verdier Eye Center
🇺🇸Grand Rapids, Michigan, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Indiana University - Glick Eye Institute
🇺🇸Indianapolis, Indiana, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
University of Miami - Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Delray Eye Associates, PA
🇺🇸Delray Beach, Florida, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Crossroads Eye Physician
🇺🇸Owings Mills, Maryland, United States
Albany Stratton VA Medical Center
🇺🇸Albany, New York, United States
NorthShore University Health System
🇺🇸Glenview, Illinois, United States
Lahey Medical Center
🇺🇸Peabody, Massachusetts, United States
Northwest Eye Clinic
🇺🇸Golden Valley, Minnesota, United States
Jennifer Burdick
🇺🇸Minnetonka, Minnesota, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
Finger Lakes Ophthalmology /The Eye Care Center
🇺🇸Canandaigua, New York, United States
Stony Brook Ophthalmology
🇺🇸East Setauket, New York, United States
Cornea Associates of Texas
🇺🇸Dallas, Texas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger Eye Clinic
🇺🇸Danville, Pennsylvania, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Prism Eye Institute
🇨🇦Oakville, Ontario, Canada
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
NY Eye Surgeons
🇺🇸Seattle, Washington, United States
Kingston Health Sciences Centre-HDH Site and Queen's University
🇨🇦Kingston, Ontario, Canada
Clinique Axe Visuel
🇨🇦Sherbrooke, Quebec, Canada
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Loma Linda University Eye Institute
🇺🇸Loma Linda, California, United States
Pacific Eye Surgeons, Inc.
🇺🇸San Luis Obispo, California, United States
Byers Eye Institute at Stanford University
🇺🇸Palo Alto, California, United States
Jules Stein Eye Clinic - UCLA
🇺🇸Los Angeles, California, United States
Colorado Cornea Consultants P.C.
🇺🇸Littleton, Colorado, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Florida Eye Specialists
🇺🇸Jacksonville, Florida, United States
EyeCare MD of NJ
🇺🇸Morristown, New Jersey, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Washington University Opthalmology
🇺🇸Saint Louis, Missouri, United States
Weill Cornell Ophthalmology
🇺🇸New York, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of Tennessee - Hamilton Eye Institute
🇺🇸Memphis, Tennessee, United States
Vantage Eye Care Center, LLC
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Cornea Consultants of Texas
🇺🇸Fort Worth, Texas, United States
Corneal Associates at Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The Research Institute of the McGill University Health Centre/McGill Academic Eye Centre
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Vanderbilt Eye Institute
🇺🇸Nashville, Tennessee, United States
Virginia Eye Institute
🇺🇸Richmond, Virginia, United States
University of British Columbia/Vancouver General Hospital Eye Care Centre
🇨🇦Vancouver, British Columbia, Canada
University of Florida
🇺🇸Gainesville, Florida, United States
LSU Health Science Center
🇺🇸New Orleans, Louisiana, United States
Wilmer Eye Institute John Hopkins
🇺🇸Bethesda, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UCSF- Francis I. Proctor Foundation
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cornea and Cataract Consultants of Nashville
🇺🇸Nashville, Tennessee, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
University of Utah - Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
Casey Eye Institute - Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
University of Kansas Medical Center
🇺🇸Prairie Village, Kansas, United States