Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Francis I. Proctor Foundation University of California, San Francisco
Collaborators:
Chulalongkorn University Huang Pacific Foundation Khon Kaen University King Chulalongkorn Memorial Hospital National Taiwan University