Clinical Trial for Cytomegalovirus Anterior Uveitis Treatments
This study is testing different ways to treat cytomegalovirus (CMV) anterior uveitis, an eye infection causing inflammation in the front of your eye. It's for adults aged 18 and older who have this condition. Researchers want to see if oral valganciclovir or ganciclovir 2% eye drops are better than a placebo (an inactive substance) at reducing the amount of CMV virus in the eye after 7 days (Trial I). They also want to know if long-term use of these antivirals can prevent the eye infection from coming back over 12 months compared to a placebo (Trial II). The study is currently unclear on its recruitment status and plans to enroll 117 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It involves two trials comparing oral valganciclovir and ganciclovir 2% eye drops against a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Trial I measures outcomes at 7 days. Trial II measures outcomes at 12 months.
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NCT07513623
Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of California, San FranciscoInvestigator-initiated
~117 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:ValganciclovirGanciclovir (GCV)Placebo
At a glance
Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure - Trial I
Measured over 7 days
+1 more outcome measured
Conditions
NCT07513623
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Chang Gung University
Taoyuan, Taiwanstudy coordinator listed
Chiang Mai University
Chiang Mai, Thailandstudy coordinator listed
Chulalongkorn University
Bangkok, Thailandstudy coordinator listed
Khon Kaen University
Khon Kaen, Thailandstudy coordinator listed
Proctor Foundation, University of California San Francisco
San Francisco, Californiastudy coordinator listed
Stein Eye Institute, University of California Los Angeles
Los Angeles, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- John A Gonzales, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Eligibility criteria
Inclusion
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
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:
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
Exclusion
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
Active anterior uveitis at the time of enrollment into Trial II, defined as ≥1+ anterior chamber cell per SUN criteria
Failure to achieve a minimum of 2 weeks of clinical inactivity (≤0.5+ anterior chamber cell) prior to enrollment into Trial II
Failure to complete a minimum 2-week washout period free from all antiviral therapy prior to randomization into Trial II
No documented prior PCR-confirmed diagnosis of CMV anterior uveitis in aqueous humor obtained during an active episode of inflammation (uveitis flare), either during Trial I participation or prior to direct Trial II enrollment
Receipt of any antiviral therapy within 14 days prior to the Trial II enrollment visit (i.e., the 2-week washout requirement has not been met)
Current use of systemic immunosuppressive therapy, including systemic corticosteroids at doses exceeding the equivalent of prednisone 10 mg/day, immunomodulatory agents, or biologic agents, at the time of Trial II enrollment
Known immunocompromising condition as defined in Trial I exclusion criterion 7 above
Abnormal laboratory values at the time of Trial II enrollment screening, using the same thresholds as defined in Trial I exclusion criterion 8 above
Pregnancy or breastfeeding at the time of Trial II enrollment. A negative pregnancy test is required for all female participants of reproductive potential prior to Trial II randomization.
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 Trial II enrollment or anticipated within the first 3 months of the Trial II follow-up period Inability or unwillingness to comply with the Trial II visit schedule, medication regimen, or study procedures for the 12-month follow-up period
Participation in another interventional clinical trial involving an investigational drug or device concurrent with Trial II participation, or within 30 days prior to Trial II enrollment
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 Trial II, adhere to the study protocol, or provide valid informed consent
What this trial measures
- Primary Outcome Measure - Trial I7 days
Trial I Aqueous Humor CMV Viral Load at Day 7
- Primary Outcome Measure - Trial II12 months
Trial II Recurrence of Anterior Uveitis Inflammation Over 12 Months