Neuro-Optical Diagnostic System for Macular Degeneration

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Age-related macular degeneration (AMD) causes progressive loss of central vision and is the leading cause of blindness in the developed world. People with AMD manifest delayed dark adaptation (DA) recovery. DA tests are a FDA approved method for diagnosing AMD in which a flash illumination bleaches rod and cone photoreceptors and the subsequent recovery is a measure of the stress response of retinal metabolism. There is an unmet need for a rapid, practical, sensitive and objective test that will provide quantitative endpoints for early diagnosis and monitoring response to newly developed treatments. Visual evoked potentials (VEP) generated in response to visual stimuli, provide a quantitative objective measure of the neuro-optical pathways and visual processes that do not require sustained attention from the patient. NeuroFieldz has developed a new system called NeuroDotVR that combines a high-resolution sensor for scalp electric potentials and fields with a smartphone powered headmount display and measures VEP objectively during DA recovery. In the Phase I STTR project 1R41AG057250-01, we developed custom stimuli for macular DA and validated the VEP measurements in normal controls and patients with confirmed diagnosis of AMD, ranging in age from 18 to 88. DA was measured simultaneously in 4 retinal locations (2 per eye) in an easy-to- administer test lasting around 15 minutes in total. The results of the Phase I proposal establish that DAVEP can be successfully implemented in a busy clinic on naïve patients with various levels of visual impairment and the test is well tolerated. All Phase I performance milestones were met. In this Phase II SBIR proposal we will further develop and validate the DA-VEPF system toward eventual 510(k) FDA approval. The project aims are: Specific Aim 1: Develop additional tests of DA-VEPF Multi-focal stimuli will be further developed and the DA-VEPF results will be correlated with other visual biomarkers. Aim 1.1 Study Compliance Monitoring. Aim 1.2 Cross threshold stimulus intensity sweeps with adaptive challenge branch. Specific Aim 2: Validate in human studies The DAVEP system will be validated in a larger cohort of 100 subjects to establish definite diagnostic criteria for early and late stage AMD. Aim 2.1 Compliant Multi-Focal Adaptive DAVEP as a function of AMD stage. Aim 2.2 Test-Retest Reliability of DAVEP as a function of AMD stage. Aim 2.3 Comparison of DAVEP and Behavioral estimates of Dark Adaptation Recovery. Aim 2.4– Advanced Signal Processing and Analytical Algorithm Development. Specific Aim 3: Enabling studies for 510(K) application In preparation for an FDA 510(k) clearance to market application, we will research: 1) Market Strategy: Customer Discovery; Reimbursement Overview; Partner Identification. 2) Regulatory Assessment for 510(k) application. 3) Scale-up manufacturing strategy.