Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Francis I. Proctor Foundation; Huang Pacific Foundation; Hwang Pacific Foundation; Khon Kaen University; King Chulalongkorn Memorial Hospital; National Taiwan University
• Treatments: Antiviral Agents; Ganciclovir; Ganciclovir triphosphate; Valganciclovir

Criteria

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