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Clarifying the Optimal Application of SLT Therapy

Award Number: UG1EY031654
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Clarifying the Optimal Application of SLT Therapy - Abstract The landmark Laser in Glaucoma and Ocular Hypertension Trial (LiGHT) recently demonstrated that in eyes with newly-diagnosed mild-moderate primary open-angle glaucoma (POAG) or high-risk ocular hypertension (OHTN), primary selective laser trabeculoplasty (SLT) was more effective than primary medical therapy (the traditional approach) in managing glaucoma, adding momentum to an SLT-first paradigm shift in glaucoma management. Anticipating that the paradigm shift will continue, we considered that an increased utilization of SLT warranted thoughtful consideration regarding our technical approach to performing SLT. A thorough literature review in 2019 led us to conclude that low energy SLT, repeated annually as maintenance therapy to the TM irrespective of IOP, would be reasonably expected to extend the duration of glaucoma control with SLT alone (avoiding the need for medications or surgery) beyond that attained with a regimen of standard energy SLT repeated as needed when its effect wears off and IOP rises (which is essentially rescue therapy). The Clarifying the Optimal Application of Selective Laser Trabeculoplasty (SLT) Therapy (COAST) trial was developed as a pair of sequential trials to answer two key questions: 1. Is low energy SLT as effective as standard energy SLT as initial (primary) therapy in lowering intraocular pressure (IOP) for 12 months? 2. Is low energy SLT repeated annually as a booster irrespective of IOP more effective than waiting for prior SLT to wear off and for IOP to rise before repeating SLT pro re nata (PRN) in controlling IOP without the need for other treatment modalities for an additional 36 months? COAST was funded in 2020 and began enrolling participants in 2021. A planned interim analysis conducted when 25% of the study sample reached the 12-month endpoint revealed that initial standard energy SLT was more effective than initial low energy SLT (survival 55%; hazard ratio 4.42, 95% confidence interval 2.25-8.68, p<0.0001) in achieving and maintaining target IOP for 12 months. Thus, the COAST study team was able to answer the first of its two clinical questions approximately 2 years earlier than anticipated. Based on recommendations from the DSMC and NEI/NIH, enrollment was paused while the protocol was revised to terminate the initial low energy SLT arm. Trial 1 was revised to a single arm cohort study in which all participants receive initial standard energy SLT; Trial 2 remains unchanged and compares retreatment strategies. Since COAST commenced, 3 independent studies indicate that first SLT may provide enduring IOP reduction for a longer period (median ~ 6 years) than suggested by data available during COAST’s design phase (~3-4 years). Consequently, we anticipate fewer failure endpoints in our control group than were projected in our statistical plan, narrowing the therapeutic window for demonstrating superiority of annual low energy SLT as an alternative strategy for long-term glaucoma therapy. We propose to extend the duration of Trial 2 from 3 to 5 years, providing 6 cumulative years of follow-up from the time of initial SLT, in order to maximize the likelihood of observing a between-group treatment difference if it exists.


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 = $406,974 )
2026	2026	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	001	6	7/1/2026	COMPETING CONTINUATION	$406,974
2026	2024	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	5	6/22/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $406,974

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	5	8/11/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,491,247 )
2024	2024	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	5	8/23/2024	NON-COMPETING CONTINUATION	$1,491,247
														Subtotal = $1,491,247

Issue Date FY: 2023 ( Subtotal = $353,963 )
2023	2023	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	4	8/23/2023	NON-COMPETING CONTINUATION	$353,963
														Subtotal = $353,963

Issue Date FY: 2022 ( Subtotal = $330,201 )
2022	2022	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	001	3	9/6/2022	NON-COMPETING CONTINUATION	$330,201
2022	2021	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	2	2/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $330,201

Issue Date FY: 2021 ( Subtotal = $380,141 )
2021	2021	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	003	2	8/30/2021	NON-COMPETING CONTINUATION	$380,141
2021	2020	WEST VIRGINIA UNIVERSITY	103 STEWART HALL	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	1	11/13/2020	NEW	-$505,595
2021	2020	WEST VIRGINIA UNIVERSITY	1500 UNIVERSITY AVE	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	002	1	8/30/2021	NEW	$0
2021	2020	WEST VIRGINIA UNIVERSITY	103 STEWART HALL	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	001	1	1/14/2021	NEW	$505,595
														Subtotal = $380,141

Issue Date FY: 2020 ( Subtotal = $505,595 )
2020	2020	WEST VIRGINIA UNIVERSITY	103 STEWART HALL	MORGANTOWN	WV	26506	MONONGALIA	USA	Vision Research	000	1	9/3/2020	NEW	$505,595
														Subtotal = $505,595

Grand Total All Awards = $3,468,121

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Clarifying the Optimal Application of SLT Therapy

Award Number: UG1EY031654

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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