Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II
University of California, San Francisco
Summary
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
Description
Cytomegalovirus (CMV) anterior uveitis is an increasingly recognized cause of recurrent and chronic ocular inflammation in immunocompetent individuals, accounting for up to 25% of anterior uveitis cases at specialized centers. The condition typically presents with unilateral hypertensive uveitis, coin-shaped or stellate keratic precipitates, and variable anterior chamber inflammation. Without adequate treatment, CMV anterior uveitis can lead to secondary glaucoma from trabecular meshwork damage and corneal endothelial decompensation, both of which may result in permanent vision loss. Diagnosis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Trial I - Inclusion Criteria * 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 * Clinical features suggestive of a viral etiology for anterior uveitis, as determined by the treating study ophthalmologist, including but not limited to one or more of the following: * Unilateral hypert…
Interventions
- DrugValganciclovir
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).
- DrugGanciclovir (GCV)
Ganciclovir 2% eye drop (compounded).
- DrugPlacebo
Placebo tablets and placebo drops.
Locations (6)
- Stein Eye Institute, University of California Los AngelesLos Angeles, California
- Proctor Foundation, University of California San FranciscoSan Francisco, California
- Chang Gung UniversityTaoyuan
- Chulalongkorn UniversityBangkok
- Chiang Mai UniversityChiang Mai
- Khon Kaen UniversityKhon Kaen