Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
Key facts
- Who runs it
- University of California, San Francisco
- Where
- San Francisco, United StatesSee the siteAlso in 1 other country, 3 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2/3
- People taking part
- 51 people enrolled
- Started
- 15 Mar 2020
- Ended
- 13 Nov 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Valganciclovir Hydrochloride
- Ganciclovir Sodium
- Placebo Oral Tablet
- Topical placebo
- Record updated
- 5 March 2026
- Why it stopped
- Funding discontinued.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Received antiviral therapy <14 days prior to enrollment
- Received periocular or intraocular corticosteroid injection < 8 weeks prior to enrollment
- Currently taking oral corticosteroids
- Prior immunosuppressive therapy in the past 6 months
- 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)
- Recent ocular surgery within the past 30 days, or planned surgery within the next 45 days
- Immunocompromised (primary or secondary immunosuppressive disorders)
- Systemic autoimmune disease or ocular condition (besides anterior uveitis) anticipated to dictate or alter treatment course
- 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
- Patients <18 years of age
- Intermediate or posterior inflammation (involvement of vitreous, choroid, or retina)
- Directed PCR negative for CMV
- Directed PCR positive for herpes simplex virus (HSV) or varicella zoster virus (VZV)
Where in United States
Also in 1 other country, 3 sites
- Proctor Foundation, UCSFSan Francisco, United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Oral ValganciclovirExisting treatment, for comparison
Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily
Treatment: Valganciclovir Hydrochloride and Topical placebo
- Topical Ganciclovir 2%Existing treatment, for comparison
Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID
Treatment: Ganciclovir Sodium and Placebo Oral Tablet
- PlaceboPlacebo, for comparison
Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID
Treatment: Placebo Oral Tablet and Topical placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment
- Record updated
- 5 March 2026