Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II

Summary

The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are:

Does oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye drops or placebo after 7 days of treatment (Trial I)? Does long-term suppressive antiviral therapy (oral valganciclovir or topical ganciclovir 2% eye drops) reduce the rate of CMV anterior uveitis recurrence over 12 months compared to placebo (Trial II)?

Researchers will compare oral valganciclovir, topical ganciclovir 2% eye drops, and placebo to see if either antiviral treatment reduces viral load and controls eye inflammation more effectively in the short term, and whether long-term antiviral suppression can prevent the disease from coming back after the inflammation has been controlled.

Participants will:

* Undergo anterior chamber paracentesis (removal of a small amount of fluid from the front of the eye) for PCR testing to confirm CMV as the cause of their eye inflammation before enrollment
* Be randomly assigned to receive oral valganciclovir 900 mg twice daily, topical ganciclovir 2% eye drops six times daily, or placebo for 7 days (Trial I), in addition to standard steroid eye drops
* Return for follow-up visits at Day 7 and Day 21 for eye examinations, laboratory blood tests, and a second anterior chamber paracentesis at Day 7 to measure viral load after treatment
* If eye inflammation is controlled after Trial I, be offered enrollment into Trial II, where they will be randomly assigned to long-term suppressive oral valganciclovir, topical ganciclovir 2% eye drops, or placebo for 12 months, with follow-up visits approximately every 2 months and additional visits if inflammation returns

Conditions

• Cytomegalovirus (CMV)
• Anterior Uveitis
• Infectious Uveitis
• CMV Infection

Interventions

DRUG

Valganciclovir

Trial I will use oral valganciclovir 450 mg tablet (2 tablets twice daily). Trial II will use oral valganciclovir 450 mg tablet (1 tablet twice daily).

DRUG

Ganciclovir (GCV)

Ganciclovir 2% eye drop (compounded).

DRUG

Placebo

Placebo tablets and placebo drops.

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• John A Gonzales, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2031-12-31

Completion

2032-10-31

FDA Drug

Yes

Countries

• United States
• Taiwan
• Thailand

Study Locations