← Back to Search

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

ZEDS 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.Check my eligibility

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.See study design

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.

ZEDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take pills and will follow the study's medication plan.

Select...

I had a shingles rash on one side of my face.

Select...

I am 18 years old or older.

Select...

I have chronic HZO and haven't taken antivirals for 30 days.

Select...

I can take pills and will follow the study's medication plan.

Select...

I have been diagnosed with shingles in one eye.

Select...

I am 18 years old or older.

ZEDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to first occurrence of Dendriform epithelial keratitis, Stromal keratitis, Endothelial keratitis or Iritis

ZEDS 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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,109 Total Patients Enrolled

National Eye Institute (NEI)NIH

546 Previous Clinical Trials

1,401,276 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,951,936 Total Patients Enrolled

Media Library

Shingles Research Study Groups: Masked Oral Valacyclovir 1000 mg daily, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA accepted Masked Oral Valacyclovir 1000 mg daily for public use?

"There is ample evidence demonstrating the security of Masked Oral Valacyclovir 1000 mg daily, so it was given a score 3."

Answered by AI

Have any previous trials explored the efficacy of administering 1000 milligrams of Masked Oral Valacyclovir per day?

"Currently, 11 studies are active that focus on the effects of Masked Oral Valacyclovir 1000 mg daily with 1 study in Phase 3. While most trials for this medication take place in Houston, Texas there are a total of 199 clinical trial sites across America."

Answered by AI

Are there any current openings in this experiment for volunteers?

"As evidenced by clinicaltrials.gov, the application process for this medical trial is still underway. The initial posting occurred on August 23rd 2017 and was most recently revised in February 25th 2022."

Answered by AI

In what geographical areas is this clinical trial being managed?

"This study has 76 different locations that are currently running, such as the Albany Stratton VA Medical Centre in Albany, Rochester's Mayo Clinic and Canandaigua's Finger Lakes Ophthalmology /The Eye Care Center."

Answered by AI

How many individuals are participating in this medical study?

"Indeed, the information on clinicaltrials.gov alludes to this medical trial being open for recruitment. This experiment was initially posted in August of 2017 and modified most recently in February 2022. In total, 780 participants are needed from 76 different sites."

Answered by AI

Has this medical trial been done before or is it a pioneering endeavor?

"Presently, 11 research studies for Masked Oral Valacyclovir 1000 mg daily are ongoing across 121 cities and 4 nations. This drug was first tested in 2006 by Millennium Pharmaceuticals Inc., involving 46 human subjects that completed Phase 2 Drug Approval trials. Since then, 64 further experiments have been conducted on this medication."

Answered by AI

What medical conditions are regularly treated with Masked Oral Valacyclovir 1000 mg daily?

"Masked Oral Valacyclovir 1000 mg daily has been proven to be an effective remedy for genital herpes, HIV-1 infection and herpes labialis."

Answered by AI

Who else is applying?

What state do they live in?

Other

Louisiana

Texas

Illinois

How old are they?

18 - 65

What site did they apply to?

University of Arkansas for Medical Sciences

NorthShore University Health System

LSU Health Science Center

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I’ve had shingles once and hope to never have it again. i sometimes still get fever blisters around my mouth with taking valacyclovir 500mg BID.

PatientReceived 1 prior treatment

I am interested in preventing an outbreak of shingles because I am aware of how debilitating it can be.

PatientReceived 2+ prior treatments

My mother had shingles twice. My brother, who had chicken pox with me as a child, had shingles in his 30’s . I had shingles in December. I want to protect myself and others from shingles and recurring shingles.

PatientReceived 2+ prior treatments