Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - … (NCT07513623) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II
United States, Taiwan, Thailand117 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hypertensive uveitis (elevated intraocular pressure in the setting of anterior chamber inflammation)
* Coin-shaped or stellate keratic precipitates
* Iris atrophy
* Corneal endothelial changes consistent with CMV endotheliitis
* Detection of cytomegalovirus (CMV) DNA by directed polymerase chain reaction (PCR) testing of aqueous humor obtained via anterior chamber paracentesis at the screening visit (Exam 0), as determined by local site PCR testing
* Willingness and ability to provide written informed consent prior to enrollment and prior to any research-specific procedures
* Willingness and ability to comply with study visit schedule, medication regimen, and study procedures for the duration of Trial I (21 days)
* For participants of reproductive potential:
* Female participants must agree to use at least one effective method of contraception during the study treatment period and for at least…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still not yet recruiting — do you know when it's expected to open, and is it worth waiting for it before we decide on a treatment plan for my CMV anterior uveitis?
2Since this is a Phase 2 trial comparing systemic and topical antiviral approaches, what does that mean for how much is already known about the safety and effectiveness of these treatments for CMV-related uveitis?
3The trial seems to have two separate parts — Trial I and Trial II — and I'd like to understand what each part involves before deciding anything, so can you walk me through what would actually be expected of me in terms of visits, medications, and monitoring if I were to participate?
4Are there already established standard-of-care treatments for CMV anterior uveitis that I should consider first, or is enrolling in a trial like this a reasonable path to discuss given my current situation?
5If I'm not eligible or the trial doesn't open in time, what other antiviral treatment options — systemic or topical — would you recommend for managing my CMV anterior uveitis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.