Zoster Eye Disease Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NYU Langone Health
Study ID
NCT03134196
Phase
PHASE4
Status
Completed

Conditions

  • Herpes Zoster Ophthalmicus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 23, 2017
Status verified
Feb 2025
Primary completion
Dec 31, 2023
Completion
Jul 22, 2024

Study Design

Enrollment
527 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Encapsulated masked placebo
  • Active Comparator: Masked Oral Valacyclovir 1000 mg daily
    Valacyclovir, 500 mg, oral pill, two 500mg pills daily

Primary Outcome Measure

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) [ Time Frame: Month 12 ]

Locations (71)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Mayo Clinic - ArizonaScottsdaleArizona85259-
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Scripps ClinicLa JollaCalifornia92037-
Loma Linda University Eye InstituteLoma LindaCalifornia92354-
Jules Stein Eye Clinic - UCLALos AngelesCalifornia90095-
Byers Eye Institute at Stanford UniversityPalo AltoCalifornia94303-
UCSF- Francis I. Proctor FoundationSan FranciscoCalifornia94131-
Pacific Eye Surgeons, Inc.San Luis ObispoCalifornia93401-
University of ColoradoAuroraColorado80045-
Colorado Cornea Consultants P.C.LittletonColorado80120-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-
Delray Eye Associates, PADelray BeachFlorida33484-
University of FloridaGainesvilleFlorida32610-
Florida Eye SpecialistsJacksonvilleFlorida33204-
University of Miami - Bascom Palmer Eye InstituteMiamiFlorida33136-
Eye Consultants of Atlanta, PCAtlantaGeorgia30339-
University of IllinoisChicagoIllinois60612-
NorthShore University Health SystemGlenviewIllinois60026-
Case Western Reserve UniversityClevelandIndiana44106-
Indiana University - Glick Eye InstituteIndianapolisIndiana46202-
University of Kansas Medical CenterPrairie VillageKansas66208-
University of KentuckyLexingtonKentucky40509-
LSU Health Science CenterNew OrleansLouisiana70112-
Shreveport Eye ClinicShreveportLouisiana71106-
The Krieger Eye InstituteBaltimoreMaryland21215-
University of MarylandBaltimoreMaryland21201-
Wilmer Eye Institute John HopkinsBethesdaMaryland20817-
Crossroads Eye PhysicianOwings MillsMaryland21117-
Boston Medical CenterBostonMassachusetts02118-
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
Lahey Medical CenterPeabodyMassachusetts01960-
Eye Health ServicesWeymouthMassachusetts02189-
University of MichiganAnn ArborMichigan48105-
Verdier Eye CenterGrand RapidsMichigan49546-
Northwest Eye ClinicGolden ValleyMinnesota55427-
Jennifer BurdickMinnetonkaMinnesota55305-
Mayo ClinicRochesterMinnesota55905-
Washington University OpthalmologySt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
EyeCare MD of NJMorristownNew Jersey07960-
Albany Stratton VA Medical CenterAlbanyNew York12208-
Finger Lakes Ophthalmology /The Eye Care CenterCanandaiguaNew York14424-
Stony Brook OphthalmologyEast SetauketNew York11733-
Northwell HealthGreat NeckNew York11021-
New York Eye and Ear InfirmaryNew YorkNew York10003-
NYU Langone HealthNew YorkNew York10016-
Weill Cornell OphthalmologyNew YorkNew York10021-
Duke UniversityDurhamNorth Carolina27710-
Cincinnati Eye InstituteCincinnatiOhio45242-
Case Western Reserve UniversityClevelandOhio44106-
Casey Eye Institute - Oregon Health and Science UniversityPortlandOregon97239-
Devers Eye InstitutePortlandOregon97210-
Vantage Eye Care Center, LLCBala-CynwydPennsylvania19004-
Geisinger Eye ClinicDanvillePennsylvania17822-
Corneal Associates at Wills Eye HospitalPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Tennessee - Hamilton Eye InstituteMemphisTennessee38163-
Cornea and Cataract Consultants of NashvilleNashvilleTennessee37203-
Vanderbilt Eye InstituteNashvilleTennessee37232-
Cornea Associates of TexasDallasTexas75231-
University of Texas SouthwesternDallasTexas75390-
Cornea Consultants of TexasFort WorthTexas76107-
Alkek Eye Center - Baylor College of MedicineHoustonTexas77030-
R and R Eye Research, LLCSan AntonioTexas78229-
University of Utah - Moran Eye CenterSalt Lake CityUtah84132-
Virginia Eye InstituteRichmondVirginia23226-
NY Eye SurgeonsSeattleWashington98133-
Virginia Mason Medical CenterSeattleWashington98101-
University of Wisconsin - MadisonMadisonWisconsin53705-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic - Arizona· Scottsdale, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARScripps Clinic· La Jolla, CALoma Linda University Eye Institute· Loma Linda, CAJules Stein Eye Clinic - UCLA· Los Angeles, CA