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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Cytomegalovirus (CMV), Anterior Uveitis, Infectious Uveitis, CMV Infection

In brief

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 facts

Study ID

NCT07513623

Run by

University of California, San Francisco

People needed

117

Starts

2026-07-01

Expected to finish

2032-10-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 30 days following the last dose of study medication
• Male participants with female partners of reproductive potential must agree to use barrier contraception during the study treatment period and for at least 90 days following the last dose of study medication
• Trial II - Inclusion Criteria
• Participants may enter Trial II via one of two pathways. All participants must meet the following general inclusion criteria:
• Age at or above the age of majority (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)
• Prior confirmed diagnosis of CMV anterior uveitis, established by positive PCR testing for CMV DNA in aqueous humor obtained via anterior chamber paracentesis during an active episode of anterior uveitis (uveitis flare). This confirmation may have been established either:
• During participation in Trial I of the current study, or
• Prior to enrollment directly into Trial II, in which case documentation of a prior positive aqueous CMV PCR result is required
• Currently clinically inactive anterior uveitis, defined as ≤0.5+ anterior chamber cell per SUN criteria, sustained for a minimum of 2 weeks prior to enrollment into Trial II
• Completion of a minimum 2-week washout period free from all antiviral therapy prior to randomization into Trial II
• Willingness and ability to provide written informed consent for Trial II participation (a separate consent process from Trial I) prior to enrollment and prior to any Trial II-specific research procedures
• Willingness and ability to comply with the Trial II visit schedule, medication regimen, and study procedures for the duration of the 12-month follow-up period
• For participants of reproductive potential:

You may not qualify if…

• Trial I - Exclusion Criteria
• 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
• Receipt of a periocular or intraocular corticosteroid injection within 8 weeks prior to the screening visit
• Current use of systemic immunosuppressive therapy, including but not limited to systemic corticosteroids (at doses exceeding the equivalent of prednisone 10 mg/day), immunomodulatory agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, cyclosporine), or biologic agents
• Known immunocompromising condition, including but not limited to:
• Human immunodeficiency virus (HIV) infection, regardless of CD4 count or viral load
• Solid organ or hematopoietic stem cell transplant recipient
• Active malignancy requiring chemotherapy or radiation therapy
• Primary or acquired immunodeficiency disorder
• Abnormal screening laboratory values, specifically:
• Absolute neutrophil count (ANC) < 500 cells/µL
• Platelet count < 25,000/µL
• Hemoglobin < 8 g/dL
• Serum creatinine > 2.5 mg/dL or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal
• Pregnancy or breastfeeding at the time of screening or enrollment. A negative pregnancy test is required for all female participants of reproductive potential prior to enrollment.
• Known hypersensitivity or prior serious adverse reaction to ganciclovir, valganciclovir, acyclovir, or any component of the study medications
• Recent or planned ocular surgery in the study eye within 30 days prior to enrollment or anticipated within the 21-day Trial I study period
• Known autoimmune disease that could independently cause anterior uveitis (e.g., HLA-B27-associated uveitis, sarcoidosis, Behçet's disease, juvenile idiopathic arthritis-associated uveitis), unless CMV is confirmed as the causative agent by positive aqueous PCR and the treating ophthalmologist determines that CMV anterior uveitis is the primary diagnosis
• Inability or unwillingness to comply with study visit schedule, medication regimen, or study procedures
• Participation in another interventional clinical trial involving an investigational drug or device within 30 days prior to enrollment, or concurrent participation in another interventional clinical trial
• Any medical, psychological, or social condition that, in the opinion of the principal investigator or site investigator, would compromise the participant's ability to safely participate in the study, adhere to the study protocol, or provide valid informed consent

Where it is running

• Stein Eye Institute, University of California Los Angeles — Los Angeles, California, United States
• Proctor Foundation, University of California San Francisco — San Francisco, California, United States
• Chang Gung University — Taoyuan, Taiwan
• Chulalongkorn University — Bangkok, Thailand
• Chiang Mai University — Chiang Mai, Thailand
• Khon Kaen University — Khon Kaen, Thailand

Full record on ClinicalTrials.gov

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