Research Project Introduction
STACCATO TriaSystemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
The STACCATO trial is a double-masked, randomized, placebo-controlled clinical study comparing oral valganciclovir and topical 2% ganciclovir for the treatment of PCR-proven CMV anterior uveitis. The study aims to determine which antiviral approach most effectively reduces CMV viral load in anterior chamber aqueous fluid.
Principal Investigator
John Gonzales, MD
Study Design
Multicenter, block-randomized, double-masked, placebo-controlled trial.
Trial Details & Objectives
- Study Arms: Oral valganciclovir, topical 2% ganciclovir, and placebo.
- Primary Outcome: Percentage reduction in CMV viral load in anterior chamber aqueous fluid after 7 days.
- Secondary Outcomes: Time to clinical quiescence and the effect of pre-enrollment topical corticosteroid use on initial viral load.
- Hypothesis: Oral valganciclovir will provide the greatest reduction in CMV viral load.
Context: CMV Anterior Uveitis Treatment
Cytomegalovirus anterior uveitis is an important cause of chronic, recurrent, unilateral hypertensive anterior uveitis in immunocompetent individuals. Diagnosis typically requires detection of CMV DNA in aqueous humor obtained through anterior chamber paracentesis.
Current management may include topical antiviral therapy, systemic antiviral therapy, or other individualized approaches. By directly comparing oral valganciclovir, topical 2% ganciclovir, and placebo, the STACCATO trial helps address an important evidence gap in determining how best to control viral replication and inflammation.
Why This Study Matters
STACCATO is designed to generate evidence that can guide treatment decisions for CMV anterior uveitis, particularly when clinicians must choose between topical and systemic antiviral strategies.
Clinical Relevance
Better antiviral control may reduce recurrent inflammation, elevated intraocular pressure, and long-term complications associated with CMV anterior uveitis.
Institutional Review Board (IRB)
Access Institutional Review Board approvals, ethics documentation, and study oversight materials related to the STACCATO trial.
Study Protocol
Review the official study protocol, including trial methodology, inclusion criteria, treatment arms, outcome measures, and statistical design.
Learn More About the Trial
View the official ClinicalTrials.gov record for study details, eligibility criteria, study arms, and outcome measures.
STACCATO Study Sites
An international, multi-site randomized clinical trial across the United States, Taiwan, and Thailand.
John Gonzales, MD
Principal Investigator
Coordinating Center
Edmund Tsui, MD, MS
Site Principal Investigator
Yih-Shiou Hwang, MD, PhD
Site Principal Investigator
Assoc. Prof. Thanapong Somkijrungroj, MD
Site PI · Head, Uveitis Unit
Wipada Laovirojjanakul, MD
Site Principal Investigator
Prof. Kessara Pathanapitoon, MD, PhD
Site Principal Investigator
Asst. Prof. Atitaya Apivatthakakul, MD, PhD
Co-Investigator · Uveitis & Retina