New trial aims to stop CMV eye inflammation from returning

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: * 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 Criteria: 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 Trial II - Exclusion Criteria * 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