Phase 2 Uveitis Trial, Not Yet Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For the first part of the trial (Trial I):

• Adults of legal adult age (18 or older in the United States; 20 or older in Thailand and Taiwan) at the time of joining
• People who currently have active inflammation at the front of the eye (anterior uveitis), with a level of eye cell activity that meets a specific medical threshold in one or both eyes at screening
• People whose eye inflammation has features suggesting it may be caused by a virus, as assessed by the treating eye specialist — for example, raised eye pressure alongside inflammation, certain types of deposits on the inner surface of the cornea, changes to the iris (coloured part of the eye), or corneal changes consistent with a specific viral infection
• People whose eye fluid test (a sample taken from the front of the eye) has come back positive for cytomegalovirus (CMV), a common virus, using a DNA detection test
• People who are willing and able to give written consent before any study procedures begin
• People who are able to attend all required visits and follow the study medication schedule for the 21-day duration of Trial I
• Women who could become pregnant must agree to use at least one effective form of contraception during treatment and for at least 30 days after the last dose of study medication
• Men with female partners who could become pregnant must agree to use barrier contraception during treatment and for at least 90 days after the last dose of study medication

For the second part of the trial (Trial II):

• Adults of legal adult age (18 or older in the United States; 20 or older in Thailand and Taiwan)
• People who have a confirmed past diagnosis of CMV-related anterior uveitis, proven by a positive DNA test on eye fluid taken during an active flare — either through participation in Trial I, or with documented proof of a prior positive result before joining Trial II directly
• People whose eye inflammation is currently inactive and has remained so for at least 2 weeks before joining Trial II
• People who have been completely free of all antiviral medications for at least 2 weeks before being assigned to a treatment group in Trial II
• People who are willing and able to provide separate written consent specifically for Trial II before any Trial II procedures begin
• People who are able to attend all required visits and follow the study medication schedule for the full 12-month follow-up period
• Women who could become pregnant must agree to use at least one effective form of contraception during treatment and for at least 30 days after the last dose of study medication
• Men with female partners who could become pregnant must agree to use barrier contraception during treatment and for at least 90 days after the last dose of study medication

Who may not be able to join:

For the first part of the trial (Trial I):

• People whose eye inflammation is currently inactive at the time of screening
• People whose primary diagnosis is a type of eye inflammation affecting the middle or back of the eye, rather than the front
• People whose eye fluid test detects herpes simplex virus (HSV) or chickenpox/shingles virus (VZV) — even if CMV is also detected at the same time
• People who have taken any antiviral medication (by mouth, injection, or eye drops) within 14 days before the screening visit
• People who have had a steroid injection in or around the eye within 8 weeks before the screening visit
• People currently taking immune-suppressing medications, including high-dose steroids, certain disease-modifying drugs (such as methotrexate or cyclosporine), or biologic therapies
• People with conditions that weaken the immune system, including HIV infection, people who have received an organ or stem cell transplant, people with an active cancer requiring chemotherapy or radiation, or people with a primary or acquired immune deficiency disorder
• People with certain abnormal blood test results at screening, including very low white blood cell counts, very low platelet counts, low haemoglobin (anaemia), poor kidney function, or significantly elevated liver enzyme levels (confirm specific thresholds with trial site)
• People who are pregnant or breastfeeding at the time of screening or joining; a negative pregnancy test is required before enrolment for women who could become pregnant
• People with a known allergy or serious past reaction to ganciclovir, valganciclovir, acyclovir, or any ingredient in the study medications
• People who have had, or are planning to have, eye surgery in the study eye within 30 days before joining or during the 21-day trial period
• People with a known autoimmune condition that could itself cause anterior uveitis (such as HLA-B27-associated uveitis, sarcoidosis, Behçet's disease, or juvenile idiopathic arthritis-related uveitis) — unless the treating ophthalmologist has confirmed that CMV is the primary cause based on a positive eye fluid test
• People who are unable or unwilling to follow the visit schedule, medication plan, or study procedures
• People who are currently in another interventional clinical trial, or who have participated in one within the past 30 days
• People whose medical, psychological, or social circumstances would, in the opinion of the principal investigator, make safe participation, protocol adherence, or providing valid consent difficult

For the second part of the trial (Trial II):

• People who have active eye inflammation at the time of joining Trial II
• People who have not had at least 2 continuous weeks of inactive eye inflammation before joining Trial II
• People who have not completed at least 2 weeks completely free of antiviral medications before being assigned to a treatment group
• People without documented proof of a prior positive CMV DNA test from eye fluid taken during an active flare — either through Trial I or prior to direct entry into Trial II
• People who have taken any antiviral medication within 14 days before the Trial II enrolment visit
• People currently taking immune-suppressing medications, including high-dose steroids, certain disease-modifying drugs, or biologic therapies
• People with conditions that weaken the immune system, as described for Trial I above
• People with the same abnormal blood test results described for Trial I above, measured at the time of Trial II enrolment screening
• People who are pregnant or breastfeeding at the time of Trial II enrolment; a negative pregnancy test is required before randomisation for women who could become pregnant
• People with a known allergy or serious past reaction to ganciclovir, valganciclovir, acyclovir, or any ingredient in the study medications
• People who have had, or are planning to have, eye surgery in the study eye within 30 days before joining Trial II or during the first 3 months of the follow-up period
• People who are unable or unwilling to follow the Trial II visit schedule, medication plan, or study procedures over the 12-month follow-up period
• People currently participating in another interventional clinical trial, or who have done so within 30 days before joining Trial II
• People whose medical, psychological, or social circumstances would, in the opinion of the principal investigator, make safe participation, protocol adherence, or providing valid consent difficult

Important: Always verify eligibility with the trial site directly before applying.