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AI-Based Identification of Rapid Glaucoma Progression to Guide Clinical Management and Accelerate Clinical Trials

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EY034424-01
Agency Tracking Number: R41EY034424
Amount: $239,790.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 100
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2023-09-29
Small Business Information
Encinitas, CA 92024-2108
United States
DUNS: 118006496
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 534-7686
Business Contact
Phone: (979) 422-4260
Research Institution
Office of Contract and Grant Administration 9500 Gilman Drive, Mail Code 0934
LA JOLLA, CA 92093-0934
United States

 Nonprofit College or University

Project Summary
Glaucoma is the leading cause of irreversible blindness worldwide and is expected to affect more than 110 million
people worldwide within the next two decades. It is a degenerative disease that has a large impact both in terms
of patient quality of life and in costs to the healthcare system. A critical need in glaucoma clinical management
and research is the ability to accurately identify patients likely to undergo rapid disease progression (i.e., lose
visual function quickly). Currently, estimating the rate of progression for a patient requires several follow-up visits
over the course of multiple years. This delay in identifying progression leads to lost vision and increases the cost
of care. It also impacts clinical trials in glaucoma, increasing the time and cost needed to investigate novel
therapies for the disease. The goal of this Phase I STTR proposal is to use artificial intelligence techniques to
improve the accuracy and shorten the time for identifying raid progression in glaucoma. The primary outcome of
our Phase I proposal will enable an AI-based tool to identify rapid glaucomatous progression and will be
immediately ready for use in Phase 1/2a clinical trials as FDA approval is not required. Specifically, we will (1)
use longitudinal optical coherence tomography (OCT) imaging and visual field (VF) testing dataset to train AI
models to identify rapidly progressing glaucoma patients and (2) incorporate patient data, clinical measurements,
and treatment history into the AI models to further improve performance. AI models will be trained and evaluated
on a combination of research and real-world clinical data. These datasets include tens of thousands of images,
VF tests, and clinical records collected from a diverse cohort of more than 9,000 glaucoma patients over the
course of more than a decade. These datasets provide us with a unique opportunity to not only train AI models,
but also to characterize model performance as a function of patient demographics, clinical covariates, disease
severity, and follow-up length – providing critical context to help clinicians better understand model predictions.
Accurate and early predictions would be of great benefit to both clinical management and clinical trials in
glaucoma. Improved outcomes, reduced patient care and drug development costs, and faster development of
glaucoma therapeutics make tools that quickly identify progressors an attractive product for our target customers,
pharmaceutical companies and eye care specialists.Project Narrative
Glaucoma is the leading cause of irreversible blindness worldwide and the inability to quickly identifying
glaucoma patients likely to undergo rapid disease progression is an ongoing problem that leads to lost vision
and an increased cost of care. Our goal is to combine artificial intelligence (AI) techniques to a large, longitudinal
dataset (9,000+ glaucoma patients, tens of thousands of clinical records) to develop and evaluate tools for
identifying rapid progression in glaucoma more quickly and more accurately. This predictive tool will be of great
benefit to both clinical management and clinical trials in glaucoma, with the potential to improve outcomes,
reduce patient care and drug development costs, and accelerate the pace of development for new glaucoma

* Information listed above is at the time of submission. *

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