Wednesday, April 24, 2024
4/24/2024
DESCRIPTION (provided by applicant): Specific Aims: 1 - to refine a novel set of low cost patent pending interactive home AMD education and monitoring tools that combine tests evaluated favorably in Phase I together with additional novel tools currently in prototype. 2 - To clinically evaluate the effectiveness of these tools in reducing the delay between onset of symptoms and presentation, thus potentially minimizing vision loss. Significance: Macular degeneration is the leading cause of blindness in those over 60. New anti-VEGF treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. In earlier studies, we have identified critical reasons for patient delay and significant gaps in the current standard of care. Our solutions address the most significant reasons for patient delay in a cost-effective format capable of distribution to millions of patients, that, if successful, will accelerate presentation and minimize vision loss for a significant population of patients. Background: There are almost 10 million people with early AMD in the US, with the number expected to rise to 17.8 million by 2050. 2,3 of this population, 10 to 15% of dry patients will eventually convert to wet AMD.4 The conversion from dry to wet AMD can occur suddenly and has been historically difficult to recognize and respond to by patients. Delays in presentation of up to 5 months are common.8 In a recent study of patients with newly diagnosed wet AMD, the most common patient-cited reasons for delay were lack of confidence in symptoms, and a lack of appreciation of the urgency of the problem. The current gold standard of home monitoring, the Amsler Grid, developed in the 1940's, does not address the top reasons for delay, nor does it address the variety of symptoms that patients experience with advancing disease. New electronic technologies for improving home monitoring AMD have demonstrated sensitivity and specificity, but their cost and learning curve can limit broad-scale distribution. A solution is required that 1) addresses the multiple reasons for delay, 2) is low-cost and amenable to distribution across large populations, 3) includes multiple interactive elements that address patient compliance and individual needs, and 4) fosters appropriate and timely action. Research design and methods: 1) conduct focus group evaluation of current prototype tools. 2) Refine the prototypes based upon patient feedback. 3) Conduct a clinical evaluation of the performance of the novel tools, measuring drop in visual acuity prior to presentation after onset of wet AMD. If successful, tools will enable broad-scale outreach, reduce educational disparities, foster routine eye exams, help accelerate patient presentation, help reduce vision loss, and help lower the socioeconomic burden of AMD. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) is the leading cause of blindness in adults over the age of 60.1 New injectable treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. The current study refines a patent pending novel group of low cost tools and assesses their ability to reduce presentation delay.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
