Valganciclovir + Ganciclovir for Cytomegalovirus Anterior Uveitis
(STACCATO I/II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are:
Does oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye drops or placebo after 7 days of treatment (Trial I)? Does long-term suppressive antiviral therapy (oral valganciclovir or topical ganciclovir 2% eye drops) reduce the rate of CMV anterior uveitis recurrence over 12 months compared to placebo (Trial II)?
Researchers will compare oral valganciclovir, topical ganciclovir 2% eye drops, and placebo to see if either antiviral treatment reduces viral load and controls eye inflammation more effectively in the short term, and whether long-term antiviral suppression can prevent the disease from coming back after the inflammation has been controlled.
Participants will:
* Undergo anterior chamber paracentesis (removal of a small amount of fluid from the front of the eye) for PCR testing to confirm CMV as the cause of their eye inflammation before enrollment
* Be randomly assigned to receive oral valganciclovir 900 mg twice daily, topical ganciclovir 2% eye drops six times daily, or placebo for 7 days (Trial I), in addition to standard steroid eye drops
* Return for follow-up visits at Day 7 and Day 21 for eye examinations, laboratory blood tests, and a second anterior chamber paracentesis at Day 7 to measure viral load after treatment
* If eye inflammation is controlled after Trial I, be offered enrollment into Trial II, where they will be randomly assigned to long-term suppressive oral valganciclovir, topical ganciclovir 2% eye drops, or placebo for 12 months, with follow-up visits approximately every 2 months and additional visits if inflammation returns
Who Is on the Research Team?
John A Gonzales, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acute Treatment (Trial I)
Participants receive oral valganciclovir, topical ganciclovir, or placebo for 7 days to evaluate short-term virologic and clinical effects.
Follow-up (Trial I)
Participants are monitored for safety and effectiveness after the acute treatment phase.
Long-Term Suppressive Therapy (Trial II)
Participants receive long-term suppressive oral valganciclovir, topical ganciclovir, or placebo for 12 months to evaluate recurrence prevention.
Follow-up (Trial II)
Participants are monitored for recurrence of anterior uveitis inflammation over 12 months.
What Are the Treatments Tested in This Trial?
Interventions
- Ganciclovir
- Valganciclovir
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Oral valganciclovir 900 mg twice daily.
Topical ganciclovir instilled into affected eye 6 times daily.
This arm does not receive antiviral therapy, but this arm will receive topical corticosteroid eye drop like the other two active arms for inflammation management.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
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