Development and Commercialization of Ocular Diagnostic Tests Based on Vitreous Pr

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$177,367.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43EY021082-01
Award Id:
96162
Agency Tracking Number:
EY021082
Solicitation Year:
n/a
Solicitation Topic Code:
NEI
Solicitation Number:
n/a
Small Business Information
901 DULANEY VALLEY ROAD, SUITE 200, TOWSON, MD, 21204
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
829021463
Principal Investigator:
BERT GLASER
() -
Business Contact:
GEORGE SCARLATIS
() -
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) is the leading cause of vision loss and blindness in people over age 60 in the developed world. Progression of this disease results in the loss of the ability to perform activities highly correlated with quality of life. The disease process is not well understood. Treatments address only portions of the underlying mechanisms of the disease and there is no cure. The current standard of care is repeated intravitreal anti-vascular endo thelial growth factor (anti-VEGF) pharmacologic treatment. However, only 34%-40% of patients gain clinically significant vision and maintain that gain over the course of one to two years. Currently non-responders are identified only after months of ineffec tive treatment. Our objective is to validate a panel of biomarkers that predict clinical non-responders to anti-VEGF monotherapy so that physicians can quickly identify patients who would benefit from alternative therapy rather than waiting for months to c linically demonstrate treatment failure before implementing these other therapeutic strategies. We have discovered the presence of cell receptors and their activated phosphorylated forms in the vitreous fluid of human eyes and that there are significant pr otein level differences between anti-VEGF treatment responders and non-responders. Ocular Proteomics, LLC (OPL)'s approach will be based on the use of reverse-phase protein microarray (RPPM) technology to accurately discriminate different disease states in at-risk patients. OPL is at the forefront of a small group that uses RPPM technology to investigate biomarkers for degenerative ocular diseases. Results will lead the way for this project to study the predictive potential of the vitreous proteome for reti nal diseases, including wet AMD. Hypotheses 1) The baseline proteome of wet AMD patients is distinctive from that of healthy normals or patients with other types of eye diseases. 2) The baseline vitreous proteome of wet AMD non-responders to anti-VEGF ther apy differs significantly from that of wet AMD responders. 3) Differences in the baseline proteome of responders and non-responders are likely to lie in proteins involved in the VEGF, angiogenesis, and/or inflammatory pathways. The Specific Aims of the pro posal are: (Aim 1) use model of clinical response to form cohorts of vitreous samples for biomarker analysis, (Aim 2) profile candidate vitreous biomarkers using antibody microarrays, and (Aim 3) validate and quantify the biomarkers. PUBLIC HEALTH R ELEVANCE: The proposed research will improve public health by improving the vision of patients with wet age-related macular degeneration at reduced costs. It will do this by producing a product that will allow retina physicians to perform a test that will determine how a patient will respond to a given treatment before starting the patient on this treatment. This will allow the doctor to choose the right treatment for the right patient at the right time, providing truly personalized medicine.

* information listed above is at the time of submission.

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