Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, San Francisco
Study ID
NCT07513623
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anterior Uveitis
  • CMV Infection
  • Cytomegalovirus (CMV)
  • Infectious Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Valganciclovir — DRUG
    Trial I will use oral valganciclovir 450 mg tablet (2 tablets twice daily). Trial II will use oral valganciclovir 450 mg tablet (1 tablet twice daily).
  • Ganciclovir (GCV) — DRUG
    Ganciclovir 2% eye drop (compounded).
  • Placebo — DRUG
    Placebo tablets and placebo drops.

Study Details

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

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2031
Completion
Oct 31, 2032

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral valganciclovir
    Oral valganciclovir 900 mg twice daily.
  • Active Comparator: Topical ganciclovir 2% eye drop
    Topical ganciclovir instilled into affected eye 6 times daily.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Primary Outcome Measure - Trial I [ Time Frame: 7 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stein Eye Institute, University of California Los AngelesLos AngelesCalifornia90095
Edmund Tsui, MD
[email protected]
310-825-5440
Proctor Foundation, University of California San FranciscoSan FranciscoCalifornia94158
John A Gonzales, MD
[email protected]
415-476-1442

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By research site
Stein Eye Institute, University of California Los Angeles· Los Angeles, CAProctor Foundation, University of California San Francisco· San Francisco, CA

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