NOT YET RECRUITING
NCT07513623
Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II
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
Gender: All
Ages: 18 Years - Any
Cytomegalovirus (CMV)
Anterior Uveitis
Infectious Uveitis
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