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Parasitic Ulcer Treatment Trial

Award Number: UG1EY033284
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Parasitic Ulcer Treatment Trial - PROJECT SUMMARY Introduction. Acanthamoeba keratitis is a blinding corneal infection with few treatment options. Corticosteroids are currently used by many cornea specialists for acanthamoeba keratitis, but their use is controversial given their ability to promote acanthamoeba growth. Trial Design. This proposed study is a randomized trial assessing whether topical corticosteroids improve clinical and visual outcomes. • Inclusion. 200 patients with microbiologic evidence of acanthamoeba keratitis (i.e., on culture, smear, or polymerase chain reaction) from 11 centers in the United States, United Kingdom, Brazil, and India will be eligible if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. • Pre-trial intervention. All participants will be treated with a standard of care anti-amoebic treatment, with the preferred treatment being polyhexamethylene biguanide (PHMB) 0.02% eyedrops. • Trial intervention. After the fourth week of anti-amoebic treatment, if there is ocular inflammation (i.e., corneal, episcleral, or anterior chamber inflammation) then participants will be offered enrollment and randomized to either topical prednisolone sodium phosphate 1% or placebo eyedrops. Participants will continue PHMB therapy while on the study medications. • Trial outcomes. The primary outcome is best corrected visual acuity with a hard contact lens, assessed at months 6 and 7. Secondary outcomes include (i) time to clinical resolution, (ii) time to perforation or therapeutic corneal transplantation, (iii) corneal thinning, (iv) eye pain, and (v) quality of life. Secondary objectives. Corneal swabs will be collected at the time of the initial diagnosis and processed with metagenomic deep sequencing to determine if endosymbiotic bacteria living within the amoeba, or the organism’s gene expression profile, is predictive of severe inflammation. Conjunctival swabs will be collected prior to randomization to determine if the host gene expression profile is predictive of severe inflammation. Impact. The trial will provide much-needed evidence using the highest-quality study design: a randomized controlled trial. Moreover, this will be the largest prospective cohort of acanthamoeba keratitis to date, with extensive microbiological, clinical, and imaging data from enrollment centers on 4 continents, which will allow numerous secondary analyses. The study results will be directly useful for providers who treat acanthamoeba keratitis as well as the patients currently affected by this blinding infection.


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 = $1,187,979 )
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	004	4	6/18/2026	SUPPLEMENT FOR EXPANSION	$6,442
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	4	6/2/2026	NON-COMPETING CONTINUATION	$1,163,537
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	003	4	6/18/2026	SUPPLEMENT FOR EXPANSION	$9,000
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	002	4	6/18/2026	SUPPLEMENT FOR EXPANSION	$9,000
2026	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	3	4/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,187,979

Issue Date FY: 2025 ( Subtotal = $1,187,979 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	3	3/26/2025	NON-COMPETING CONTINUATION	$1,187,979
														Subtotal = $1,187,979

Issue Date FY: 2024 ( Subtotal = $1,318,003 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	002	2	7/18/2024	SUPPLEMENT FOR EXPANSION	$138,099
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	001	2	4/12/2024	NON-COMPETING CONTINUATION	$1,179,904
2024	2023	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	4/11/2024	NEW	$0
														Subtotal = $1,318,003

Issue Date FY: 2023 ( Subtotal = $1,562,129 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Vision Research	000	1	9/19/2023	NEW	$1,562,129
														Subtotal = $1,562,129

Grand Total All Awards = $5,256,090

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Parasitic Ulcer Treatment Trial

Award Number: UG1EY033284

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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