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Antiviral

Oral Valacyclovir for Shingles Eye Disease (ZEDS Trial)

Phase 4
Waitlist Available
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication, and are willing to adhere to study medication regimen.
- History of characteristic unilateral, usually vesicular, HZO rash in the dermatomal distribution of cranial nerve V1 or V2.
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether the drug valacyclovir can help prevent further episodes of HZO in people who have already had at least one episode.

Who is the study for?
Adults over 18 with a history of Herpes Zoster Ophthalmicus (HZO) affecting the eye, who can take oral medication and follow study procedures. Women must use effective contraception if of childbearing potential. Excludes those with certain cancers, immunodeficiencies like AIDS/HIV, pregnant or nursing women not using contraception, recent zoster vaccination recipients, and individuals on specific antivirals or immune therapies.
What is being tested?
The trial is testing the effectiveness of an oral drug called Valacyclovir in preventing recurrence of HZO-related eye disease compared to a placebo. Participants will be randomly assigned to either the drug or placebo group without knowing which they are receiving (double-masked), and followed for one year.
What are the potential side effects?
Valacyclovir may cause side effects such as headache, nausea, stomach pain, vomiting, dizziness. Rarely it might lead to more serious issues like kidney problems especially if you have existing kidney conditions or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and will follow the study's medication plan.
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I had a shingles rash on one side of my face.
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I am 18 years old or older.
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I have chronic HZO and haven't taken antivirals for 30 days.
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I can take pills and will follow the study's medication plan.
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I have been diagnosed with shingles in one eye.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or if I can have children, I agree to use birth control during treatment.
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I haven't had major eye surgery, except for specific types during cataract surgery, in the last 5 years.
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I have AIDS or HIV with a CD4 count of 200 or less.
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My kidney function is not normal but meets specific criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis
Secondary study objectives
Number of patients who develop secondary glaucoma
Number of patients who develop specific manifestations of Herpes Zoster Ophthalmicus (HZO)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Masked Oral Valacyclovir 1000 mg dailyActive Control1 Intervention
Valacyclovir, 500 mg, oral pill, two 500mg pills daily
Group II: PlaceboPlacebo Group1 Intervention
Encapsulated masked placebo

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,413 Previous Clinical Trials
855,098 Total Patients Enrolled
National Eye Institute (NEI)NIH
556 Previous Clinical Trials
1,406,818 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,165,904 Total Patients Enrolled
Elisabeth Cohen, MDStudy ChairNYU Langone Health

Media Library

Shingles Research Study Groups: Masked Oral Valacyclovir 1000 mg daily, Placebo
~79 spots leftby Dec 2025
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