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Antiviral

Antivirals for Cytomegalovirus Uveitis (STACCATO Trial)

Phase 2 & 3
Recruiting
Led By John A Gonzales, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Directed PCR positive for CMV OR previous PCR-proven CMV anterior uveitis
Be older than 18 years old
Must not have
Immunocompromised (primary or secondary immunosuppressive disorders)
Directed PCR positive for herpes simplex virus (HSV) or varicella zoster virus (VZV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 28 (final visit)

Summary

This trial is comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis.

Who is the study for?
This trial is for adults with a clinical diagnosis of CMV anterior uveitis confirmed by PCR, who are willing to use contraception. It excludes those under 18, with certain eye conditions or recent treatments, pregnant or breastfeeding women, individuals on oral steroids or immunosuppressives, and anyone planning surgery within specified timeframes.
What is being tested?
The study compares the effectiveness of an oral drug (Valganciclovir Hydrochloride), a topical medication (Ganciclovir Sodium), and placebos in treating CMV anterior uveitis. This double-masked trial randomly assigns participants to these treatments to determine optimal therapy routes.
What are the potential side effects?
Oral Valganciclovir may cause blood and kidney side effects requiring lab monitoring. Topical Ganciclovir's side effects aren't well established but could include local eye irritation. Placebo groups should not experience active drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tested positive for CMV or had CMV eye inflammation before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that weakens my immune system.
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I have tested positive for herpes or shingles virus.
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I am not planning to get pregnant, and I am not currently pregnant or breastfeeding.
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I have not had eye surgery in the last 30 days and do not plan to in the next 45 days.
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I am under 18 years old.
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My eye condition affects the middle or back parts of my eye.
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I am currently taking oral corticosteroids.
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I have an autoimmune disease or eye condition that could affect my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 28 (final visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 28 (final visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in viral load
Secondary study objectives
Effect of topical corticosteroid
Percent that achieved clinical quiescence

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Oral ValganciclovirActive Control2 Interventions
Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily
Group II: Topical Ganciclovir 2%Active Control2 Interventions
Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID
Group III: PlaceboPlacebo Group2 Interventions
Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID

Find a Location

Who is running the clinical trial?

King Chulalongkorn Memorial HospitalOTHER
61 Previous Clinical Trials
235,813 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,077 Total Patients Enrolled
Huang Pacific FoundationUNKNOWN

Media Library

Ganciclovir Sodium (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03586284 — Phase 2 & 3
Cytomegalovirus Uveitis Research Study Groups: Oral Valganciclovir, Placebo, Topical Ganciclovir 2%
Cytomegalovirus Uveitis Clinical Trial 2023: Ganciclovir Sodium Highlights & Side Effects. Trial Name: NCT03586284 — Phase 2 & 3
Ganciclovir Sodium (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03586284 — Phase 2 & 3
~5 spots leftby Mar 2025
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