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Systemic and Topical Antiviral Control of Cytomegalovirus Anterior uveitis: TreatmentOutcomes (STACCATO)

Award Number: UG1EY036344
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 01/31/2031

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Systemic and Topical Antiviral Control of Cytomegalovirus Anterior uveitis: TreatmentOutcomes (STACCATO) - PROJECT SUMMARY/ABSTRACT Cytomegalovirus anterior uveitis is an increasingly recognized but underestimated cause of ocular inflammation, accounting for up to 25% of anterior uveitis cases at specialized centers. While CMV infection was historically associated with retinitis in immunocompromised patients, its role in anterior uveitis among immunocompetent individuals represents a significant public health challenge that can lead to blindness through complications including glaucoma and corneal decompensation. The disease has been particularly noted in Asian and Asian-American populations, though increasing diagnostic capabilities suggest it affects all demographic groups. Recent evidence suggests multiple anterior chamber paracenteses may be required for accurate diagnosis, indicating current prevalence estimates likely underestimate the true disease burden. Treatment strategies may include oral antiviral therapy with valganciclovir but can be expensive and requires laboratory monitoring for side effects of renal toxicity and bone marrow suppression. Topical antiviral therapy with ganciclovir eye drops is an alternative approach but requires medication compounding and expires quickly. Yet another treatment approach may be simple observation without using any antivirals. Despite these options, the optimal therapeutic approach remains undefined due to a lack of comparative trials. Furthermore, while long-term antiviral suppression may prevent disease recurrence, no randomized controlled trials have established efficacy or investigated how mutations might lead to treatment resistance. Here we seek to enroll participants with PCR-proven CMV anterior uveitis into two double-masked placebo- controlled randomized clinical trials in the US and Asia to 1) compare CMV viral load and inflammation after randomization to 7 days of oral valganciclovir, topical ganciclovir 2%, or placebo (Trial I); 2) evaluate the effect of long-term antiviral suppression on CMV recurrence after achieving a clinical quiescence (Trial II); and 3) investigate viral resistance patterns and host immune responses using advanced genomic analysis of aqueous samples from both trials to understand mechanisms of recurrent disease. This proposal will establish evidence-based protocols for both acute treatment and long-term management of CMV anterior uveitis. Our innovative approach combines microbiologic and clinical outcomes with molecular analysis to understand disease mechanisms, potentially identifying biomarkers for recurrence and antiviral resistance. These findings will directly impact patient care by optimizing treatment approaches and preventing vision loss in this significant subset of uveitis patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $492,815 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	1	5/11/2026	NEW	$492,815
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	001	1	5/13/2026	NEW	$0
														Subtotal = $492,815

Grand Total All Awards = $492,815

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Systemic and Topical Antiviral Control of Cytomegalovirus Anterior uveitis: TreatmentOutcomes (STACCATO)

Award Number: UG1EY036344

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 01/31/2031

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