Trial Outcomes & Findings for Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (NCT NCT03586284)

Last Updated: 2026-03-05

Results Overview

Pre-treatment minus day-7 CMV DNA load in aqueous humor, reported as log10 IU/mL (WHO-standardized qPCR). Positive values indicate reduction.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

51 participants

Primary outcome timeframe

7 days

Results posted on

2026-03-05

Participant Flow

Prospective recruitment at three uveitis centers (UCSF, Chulalongkorn, Khon Kaen) Jan 2020-Mar 2024 during routine care of adults with active anterior uveitis. Eligibility: ≥1+ AC cells and CMV+ by AC PCR; key exclusions: recent antivirals/steroids, systemic IS, HSV/VZV. 51 randomized (1:1:1; site-stratified blocks) to valganciclovir, 2% ganciclovir, or placebo; 47 completed day-7 sampling. Enrollment ended early due to COVID-related delays/funding.

Adults with active anterior uveitis gave consent, had slit-lamp exam and anterior chamber paracentesis. Local PCR confirmed CMV and excluded HSV/VZV. While awaiting results, candidates received standard-of-care topical steroids/IOP meds. Washouts: no antivirals ≤14 days; no peri/intraocular steroid ≤8 weeks. Eligible participants completed baseline measures, then were randomized via site-stratified, concealed allocation with masked tablets/drops.

Participant milestones

Participant milestones
Measure	Oral Valganciclovir Oral valganciclovir 900 mg PO BID	Topical Ganciclovir 2% Topical ganciclovir 2% 1 drop applied 6 times daily	Placebo Topical placebo solution 1 drop applied 6 times daily
Overall Study STARTED	19	15	17
Overall Study COMPLETED	19	13	15
Overall Study NOT COMPLETED	0	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Valganciclovir n=19 Participants Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily	Topical Ganciclovir 2% n=15 Participants Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID	Placebo n=17 Participants Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID	Total n=51 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 15.2 • n=41 Participants	59.3 years STANDARD_DEVIATION 9.9 • n=35 Participants	51.7 years STANDARD_DEVIATION 18.5 • n=76 Participants	54.7 years STANDARD_DEVIATION 15.2 • n=565 Participants
Sex: Female, Male Female	9 Participants n=41 Participants	8 Participants n=35 Participants	7 Participants n=76 Participants	24 Participants n=565 Participants
Sex: Female, Male Male	10 Participants n=41 Participants	7 Participants n=35 Participants	10 Participants n=76 Participants	27 Participants n=565 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Asian	18 Participants n=41 Participants	14 Participants n=35 Participants	16 Participants n=76 Participants	48 Participants n=565 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) White	1 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=76 Participants	3 Participants n=565 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Includes randomized participants with paired baseline and day-7 aqueous qPCR results (oral 19/19, topical 13/13, placebo 15/15).

Pre-treatment minus day-7 CMV DNA load in aqueous humor, reported as log10 IU/mL (WHO-standardized qPCR). Positive values indicate reduction.

Outcome measures

Outcome measures
Measure	Oral Valganciclovir n=19 Participants Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily	Topical Ganciclovir 2% n=13 Participants Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID	Placebo n=15 Participants Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID
Change in CMV Viral Load	0.59 log10 IU/mL Standard Deviation 0.87	0.23 log10 IU/mL Standard Deviation 0.59	0.04 log10 IU/mL Standard Deviation 0.44

SECONDARY outcome

Timeframe: Day 0 to Day 21 (final visit)

Comparison between arms of percent that achieved clinical quiescence by final visit (anterior chamber cell ≤ 0.5+).

Outcome measures

Outcome measures
Measure	Oral Valganciclovir n=19 Participants Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily	Topical Ganciclovir 2% n=13 Participants Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID	Placebo n=15 Participants Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID
Number of Participants That Achieved Clinical Quiescence	19 Participants	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 0 (pre-treatment) viral load (IU/mL)

What effect did topical corticosteroid use prior to enrollment have on pre-treatment viral load (Day 0)

Outcome measures

Outcome measures
Measure	Oral Valganciclovir n=19 Participants Oral Valganciclovir 900mg PO BID Topical placebo solution, 1 drop applied 6 times daily	Topical Ganciclovir 2% n=13 Participants Topical Ganciclovir 2% solution, 1 drop applied 6 times daily Placebo pills PO BID	Placebo n=15 Participants Topical placebo solution, 1 drop applied 6 times daily Placebo pills PO BID
Effect of Topical Corticosteroid	0.10 IU/mL Interval -0.06 to 0.26	0.10 IU/mL Interval -0.06 to 0.26	0.10 IU/mL Interval -0.06 to 0.26

Adverse Events

Topical Ganciclovir 2%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Valganciclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Gonzales, MD

F.I. Proctor Foundation, University of California, San Francisco

Phone: 415-476-1442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place