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
Age at or above the age of majority at the time of enrollment (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)
Presenting with active anterior uveitis, defined as ≥1+ anterior chamber cell per -Standardization of Uveitis Nomenclature (SUN) Working Group criteria, in one or both eyes at the time of screening
Unilateral hypertensive uveitis (elevated intraocular pressure in the setting of anterior chamber inflammation)
Coin-shaped or stellate keratic precipitates
Inactive anterior uveitis (≤0.5+ anterior chamber cell per SUN criteria) at the time of screening or enrollment
Intermediate uveitis, posterior uveitis, or panuveitis as the primary diagnosis, with or without concurrent anterior segment involvement
Detection of herpes simplex virus (HSV) or varicella zoster virus (VZV) by directed PCR testing of aqueous humor obtained at the screening paracentesis, regardless of whether CMV is also detected
Receipt of any antiviral therapy (systemic or topical ophthalmic) within 14 days prior to the screening visit
Parallel
Valganciclovir
DrugTrial 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)
DrugGanciclovir 2% eye drop (compounded).
Placebo
DrugPlacebo tablets and placebo drops.
Primary Outcome Measure - Trial I
Trial I Aqueous Humor CMV Viral Load at Day 7
Primary Outcome Measure - Trial II
Trial II Recurrence of Anterior Uveitis Inflammation Over 12 Months
Secondary Outcome Measure - Trial I
Trial I proportion of patients achieving clinical inactivity of anterior chamber inflammation at Day 7
Secondary Outcome Measure Trial I at 21 days
Trial I Clinical proportion of patients achieving clinical inactivity of anterior chamber Inflammation at Day 21
Trial I intraocular pressure at 7 days
Trial I Intraocular Pressure at Day 7
Intraocular pressure at 21 days
Trial I Intraocular Pressure at Day 21
Trial topical ganciclovir 2% vs placebo
Trial I Topical Ganciclovir 2% Versus Placebo: Post-Treatment CMV Viral Load at Day 7 (Subsidiary Analysis)
Prevalence of CMV antiviral resistance mutations in Trial II recurences
Trial II Prevalence of CMV Mutations Conferring Antiviral Resistance at Time of Recurrence
Host transcriptional profiles
Specific Aim 3 Host Transcriptional Signatures in CMV Anterior Uveitis (Translational)
Time to first recurrence during Trial II
Trial II Time to First Recurrence of Inflammation
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
