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Characterization of vascular responses to intravitreal anti-VEGF injections in diabetic retinopathy

Award Number: R01EY027301
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2029

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Characterization of vascular responses to intravitreal anti-VEGF injections in diabetic retinopathy - Diabetic retinopathy (DR) is the most prevalent retinal vascular disease worldwide causing visual impairment and blindness in nearly 8 million Americans. Over the past two decades, the use of intravitreal anti-VEGF therapy for proliferative DR has been studied extensively and has been shown to be effective for improving visual acuity and preventing progression. However, studies regarding the impact of VEGF blockage on the status of retinal vascular perfusion have produced controversial and contradictory findings. Central to this dilemma is tremendous variability and weak correlation of treatment-monitoring biomarkers to clinical outcomes. Vascular metrics such as capillary density and foveal avascular zone area as currently measured have not proven consistently sensitive enough to detect and monitor clinical DR improvement or progression. To address this knowledge gap, we propose the use of two non-invasive high-resolution retinal imaging techniques to identify subclinical microvascular changes, quantify perfusion, and visualize cellular changes in DR, namely adaptive optics scanning light ophthalmoscopy (AOSLO) and optical coherence tomography angiography (OCTA). In our preliminary work, we developed several highly-reliable retinal vascular metrics, developed age/race/sex- matched normative databases, and showed that categorized perfusion changes, outperformed currently available vascular metric for monitoring anti-VEGF treatment response in DR. Our hypothesis is that our new approaches to AOSLO and OCTA quantitative image analysis will generate biomarkers which are more sensitive and better suited to guide treatment by overcoming clinical uncertainties in DR management. We propose to conduct a prospective cohort study using retinal imaging and clinical data collection to 1) further improve our AO ophthalmoscope for precise structural and functional measurements, 2) validate our custom vascular metrics for early DR detection and as objective indicators of disease severity, and 3) characterize short-term anti-VEGF treatment response in DR. To accomplish these important goals, the proposed project brings together expertise in optical design and engineering, retinal imaging, and ophthalmology.


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: 2025 ( Subtotal = $697,579 )
2025	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	002	7	7/10/2025	NON-COMPETING CONTINUATION	$697,579
2025	2024	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	001	6	2/19/2025	COMPETING CONTINUATION	$170,054
2025	2021	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	5	2/19/2025	NON-COMPETING CONTINUATION	-$170,054
														Subtotal = $697,579

Issue Date FY: 2024 ( Subtotal = $598,447 )
2024	2024	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	6	5/14/2024	COMPETING CONTINUATION	$598,447
														Subtotal = $598,447

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	5	4/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $406,473 )
2021	2021	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	5	5/10/2021	NON-COMPETING CONTINUATION	$406,473
														Subtotal = $406,473

Issue Date FY: 2020 ( Subtotal = $419,364 )
2020	2020	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	4	5/15/2020	NON-COMPETING CONTINUATION	$419,364
														Subtotal = $419,364

Issue Date FY: 2019 ( Subtotal = $419,698 )
2019	2019	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	3	4/15/2019	NON-COMPETING CONTINUATION	$419,698
														Subtotal = $419,698

Issue Date FY: 2018 ( Subtotal = $391,642 )
2018	2018	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	2	4/27/2018	NON-COMPETING CONTINUATION	$391,642
														Subtotal = $391,642

Issue Date FY: 2017 ( Subtotal = $417,722 )
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Vision Research	000	1	4/25/2017	NEW	$417,722
														Subtotal = $417,722

Grand Total All Awards = $3,350,925

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Characterization of vascular responses to intravitreal anti-VEGF injections in diabetic retinopathy

Award Number: R01EY027301

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2029

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