Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (NCT03586284) | Clinical Trial Compass
TerminatedPhase 2/3
Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
Stopped: Funding discontinued.
United States, Thailand51 participantsStarted 2020-03-15
Plain-language summary
Cytomegalovirus (CMV) is generally a latent and asymptomatic infection in healthy, immunocompetent individuals. In immunocompromised patients CMV is well known to cause a retinitis that can lead to blindness. In immunocompetent patients, however, CMV can cause recurrent inflammation in the front of the eye (anterior uveitis). CMV anterior uveitis produces complications including pain, glaucoma, corneal failure, and vision loss. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis and treated as such, which can beget further complications. Diagnosis requires directed polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying the appropriate therapy has been challenging because no randomized trials comparing routes of therapy (particularly oral or topical) have been performed. Oral antiviral therapy of CMV carries blood and kidney side effects that requires laboratory monitoring. Topical therapy has been reported to be effective, but no consensus as to the appropriate drug concentration exists.
Here we propose a double-masked randomized controlled clinical trial comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis. This pilot study will provide valuable information concerning the treatment of CMV anterior uveitis with oral and topical medications, including effective concentrations and side-effect profile. The information obtained from this study will help inform future larger clinical trials in CMV anterior uveitis.
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:
* Clinical impression consistent with CMV anterior uveitis
* Directed PCR positive for CMV OR previous PCR-proven CMV anterior uveitis
* Willingness to use an acceptable method of contraception during the study period (i.e.
pharmacologic, devices, barrier methods) or abstinence.
Exclusion Criteria:
* Patients \<18 years of age
* Intermediate or posterior inflammation (involvement of vitreous, choroid, or retina)
* Received antiviral therapy \<14 days prior to enrollment
* Received periocular or intraocular corticosteroid injection \< 8 weeks prior to enrollment
* Currently taking oral corticosteroids
* Immunocompromised (primary or secondary immunosuppressive disorders)
* Prior immunosuppressive therapy in the past 6 months
* Directed PCR negative for CMV
* Directed PCR positive for herpes simplex virus (HSV) or varicella zoster virus (VZV)
* Planning to conceive during the study period, pregnant or breast-feeding (blood or urine pregnancy test for all females of child-bearing age is mandatory within 4 weeks prior to enrollment)
* Complete blood count with white blood cell, absolute neutrophil, or platelet count lower than the lower limit of reference laboratory normal
* BUN or Cr above the upper limit of reference laboratory normal
* Recent ocular surgery within the past 30 days, or planned surgery within the next 45 days
* Systemic autoimmune disease or ocular condition (besides anterior uveitis) anticipated to dictate or alter treatment course
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 was terminated before completing — does that mean there were safety concerns, or was it stopped for another reason, and how does that affect what we know about using antivirals for CMV anterior uveitis?
2The trial was comparing systemic and topical antiviral treatments and measuring how well they reduced CMV viral load in the eye — based on whatever data was collected before it stopped, is there any signal about which approach might work better for my situation?
3Since this was a Phase 2/3 trial, the treatments were still being evaluated for effectiveness — are there already approved or standard-of-care antiviral options for CMV anterior uveitis that have more established safety and benefit data I should consider first?
4Long-term antiviral use, especially systemic medications, can sometimes affect the kidneys or other organs — given that this trial didn't complete, what do we know about the safety profile of the treatments it was studying, and how would that affect my risk?
5Are there other ongoing or completed trials studying antivirals for CMV anterior uveitis that might be worth looking into, since this one was terminated before reaching its conclusions?
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.