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NCT03586284 · ClinicalTrials.gov registry record · Phase 2
Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT03586284: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT03586284 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03586284, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
Pre-treatment minus day-7 CMV DNA load in aqueous humor, reported as log10 IU/mL (WHO-standardized qPCR). Positive values indicate reduction.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Valganciclovir Hydrochloride
- DRUG Ganciclovir Sodium
- DRUG Topical placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-03-15 |
| Est. Completion | 2024-11-13 |
| Phase | Phase 2 |
Why NCT03586284 stopped before completion
NCT03586284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Tablet is the first listed.
NCT03586284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03586284 about?
NCT03586284 is a clinical study titled "Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes". 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 ...
What is the current status of trial NCT03586284?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2020-03-15. Estimated completion is 2024-11-13.
What interventions are being tested in trial NCT03586284?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Valganciclovir Hydrochloride (DRUG), Ganciclovir Sodium (DRUG), Topical placebo (DRUG).
Who is sponsoring clinical trial NCT03586284?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03586284's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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