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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 28 (final visit)
Awards & highlights
STACCATO Trial 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.Check my eligibility
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.See study design
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.
STACCATO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tested positive for CMV or had CMV eye inflammation before.
STACCATO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 28 (final visit)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 28 (final visit)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in viral load
Secondary outcome measures
Effect of topical corticosteroid
Percent that achieved clinical quiescence
STACCATO 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
58 Previous Clinical Trials
225,420 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,456 Total Patients Enrolled
Huang Pacific FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that weakens my immune system.I have tested positive for herpes or shingles virus.I have not taken antiviral medication in the last 14 days.I am not planning to get pregnant, and I am not currently pregnant or breastfeeding.I have not had immunosuppressive therapy in the last 6 months.My eye inflammation is likely due to CMV infection.I have not had eye surgery in the last 30 days and do not plan to in the next 45 days.I have tested positive for CMV or had CMV eye inflammation before.I am under 18 years old.My eye condition affects the middle or back parts of my eye.I am currently taking oral corticosteroids.I have an autoimmune disease or eye condition that could affect my treatment.I have not had eye steroid injections in the last 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Valganciclovir
- Group 2: Placebo
- Group 3: Topical Ganciclovir 2%
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Oral Valganciclovir typically used?
"Oral Valganciclovir is a medication used to fight cytomegalovirus infections, but it can also help patients dealing with acquired immunodeficiency syndrome, kidney, and hiv."
Answered by AI
Are there precedent studies to support the use of Oral Valganciclovir?
"At the moment, there are 15 ongoing studies related to Oral Valganciclovir with 6 Phase 3 trials. Most of these are based in Barcelona and Cantabria, but there are 205 locations running these trials in total."
Answered by AI
How large is this clinical trial in terms of participants?
"That is correct, the clinicaltrials.gov website contains information suggesting that this study is still enrolling patients. The first posting date was March 15th, 2020 and the most recent update was on July 1st, 2022. Currently, the study has room for 99 patients at a single location."
Answered by AI
Are people who suffer from the target ailment able to participate in the trial at this time?
"The trial is still recruiting patients, as seen on clinicaltrials.gov. The trial was first posted on March 15th, 2020, and was updated on July 1st, 2022."
Answered by AI
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