Phase I Amount
$2,988,224
Summary Abstract Second Sight(r) Medical Products, Inc. (SSMP) has been developing retinal prostheses for over 10 years. Currently, the company is sponsoring a feasibility clinical trial for its Argus(tm) II system - a 60 electrode retinal prosthesis to treat advanced retinitis pigmentosa (RP). This trial has enrolled 32 subjects, including 14 subjects in the United States. The next step on the path to commercialization will be to conduct a Pre-Market Approval clinical study (PMA) in the U.S. In order to conduct such a study, pre-defined endpoints must be identified to measure improvements in basic visual function and visual performance on real-world tasks. Today, few accepted measures exist for quantifying the vision of severely visually impaired individuals, and no standardized endpoints have been established to determine a successful outcome for a PMA trial. These represent significant barriers to commercialization because successful completion of a PMA trial and demonstration of meaningful improvements in visual function and visual performance are critical to the commercial success of a retinal prosthesis like the Argus(tm) II. We propose to develop new testing methodologies to quantify improvements in vision and define meaningful endpoints for a PMA study. With our extensive clinical experience, we are uniquely positioned to carry out this research. In addition, we propose to develop a suite of software and hardware tools with which to perform these assessments, and to make them available to other U.S.-based low vision researchers. Successful completion of our specific aims will result in allowing a pivotal trial to proceed, which is the next step in the commercialization of the Argus(tm) II retinal prosthesis, which is aimed at significantly improving the quality of life for tens of thousands of Americans who currently have no alternative form of treatment.
Public Health Relevance: Project Narrative is not required for BRDG-SPAN
Public Health Relevance Statement: Project Narrative is not required for BRDG-SPAN
Project Terms: abstracting; Activities of Daily Living; Activities of everyday life; Address; American; Area; base; Change of Life; Climacteric; Clinic; Clinical; clinical investigation; Clinical Research; clinical significance; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; clinically significant; commercialization; Complete Blindness; computer program/software; Computer Programs; Computer software; Computers; daily living functionality; Data; develop software; developing computer software; Development; Devices; Economics; Electrodes; enroll; Enrollment; experience; FDA approved; flexibility; functional ability; functional capacity; Goals; Grant; heavy metal lead; heavy metal Pb; improved; Individual; Investigators; Lead; Letters; Light; Marketing; Measures; Medical; Method LOINC Axis 6; Methodology; Methods; Outcome; Partial Sight; patient population; Patients; Pattern; Pb element; Perception; Performance; Photoradiation; Pigmentary Retinopathy; Population; Position; Positioning Attribute; Procedures; Prosthesis; Prosthetic device; Prosthetics; Protocol; Protocols documentation; public health relevance; Publishing; QOL; Quality of life; Recovery; Research; Research Personnel; Researchers; Retinal; retinal prosthesis; Retinitis Pigmentosa; Rod-Cone Dystrophy; Safety; Sight; skills; Software; software development; Specific qualifier value; Specified; Staging; success; System; System, LOINC Axis 4; Tapetoretinal Degeneration; Testing; tool; United States; Validation; Vision; Vision, Diminished; Vision, Low; Vision, Reduced; Vision, Subnormal; Visual Acuity; Visual impairment; visual performance; visually impaired
