SBIR-STTR Award

Apeliotus Technologies proposes to develop a commercial diagnostic for the early detection of age-related macular degeneration (ARMD). It relies on a functional test of dark adaptation kinetics (the transition from being light-adapted to being dark-adapted) that has been shown in previous work to detect the onset of ARMD at least four years before it is clinically evident. Testing is completely non-invasive and can be performed by an unskilled operator with a minimum of patient burden. ARMD is the leading cause of untreatable blindness for older adults in developed countries, affecting an estimated 30 million people worldwide and 13 million people in the US. The problem is expected to get significantly worse as the population ages. One challenge in addressing this health threat is the development of methods to discriminate normal aging from early (sub-clinical) disease onset. The proposed ARMD diagnostic has tremendous potential as a doctor's office screening tool for identification of at-risk and treatment populations. Equally important, it can provide a sensitive outcome measure for evaluating the early-stage impact of the many drugs and nutritional supplements being developed for ARMD. Developing these capabilities could result in substantially improved quality of life for older adults. The overall goal of this program is to demonstrate =90% sensitivity and =90% specificity for early-stage ARMD using the proposed diagnostic with a simple, rapid test protocol. The specific aim of this Phase I proposal is to demonstrate the feasibility of discriminating early-stage ARMD patients from normal old adults in = 20 minutes. A preliminary commercial prototype will be built with device parameters and a test protocol optimized for rapid determination of dark adaptation impairment, and a 40-person clinical study (20 early-stage ARMD patients; 20 normal old adults) will be conducted to confirm that discrimination is possible within the targeted time.

Thesaurus Terms:
diagnosis design /evaluation, diagnosis quality /standard, eye disorder diagnosis, macular degeneration aging, disease /disorder onset, early diagnosis, light adaptation, mass screening, noninvasive diagnosis clinical research, human subject, young adult human (21-34)

This is an SBIR Phase II proposal directed at the continued development of a diagnostic for the early detection of age-related macular degeneration (AMD). It relies on a functional test of dark adaptation kinetics (the transition from being light-adapted to being dark-adapted) that has been shown in previous work to detect the onset of AMD at least four years before it is clinically evident. Testing is completely non-invasive and can be performed by an unskilled operator with a minimum of patient burden. Our Phase I aim was to demonstrate feasibility by building a preliminary prototype diagnostic that could distinguish AMD patients from normal old adults in = 20 minutes. This aim was easily achieved. A range of early to late AMD patients was readily discriminated from clinically normal old adults in = 20 minutes. The difference was both substantial (~100% dark adaptation impairment for AMD patients relative to normal old adults) and statistically significant (t = 6.02; p < 0.0001). Diagnostic sensitivity and specificity were 88% and 100%, respectively, with the degree of dark adaptation impairment tracking disease severity. Finally, there is promising pilot data for follow-on development of a commercial AMD screening test that can be completed in = 10 minutes. Our Phase II aim is to build a robust commercial prototype and evaluate the diagnostic sensitivity and specificity for detection of early AMD in a cross-sectional study of 200 patients (50% normal old adults; 50% having a range of early to intermediate AMD). Our goal is sensitivity and specificity = 90% with a test duration = 10 minutes. The University of Alabama at Birmingham and Johns Hopkins University will serve as clinical test sites. Age-related macular degeneration (AMD) is the leading cause of blindness for individuals in developed countries over 50 years old. It already affects more than 13 million people in the US, including one-third of those over 75, and the problem is expected to get worse as the population ages. Unfortunately, there is no simple means for early detection. A diagnostic for early AMD could aid in the development of early-stage treatments and identify individuals for intervention before the devastation of late-stage vision loss