SBIR-STTR Award

Age-related macular degeneration (AMD) continues to be the leading cause of central vision loss in the US today for those over fifty years of age and will likely become epidemic as Baby Boomers reach retirement age. Over the last 15 years treatments have become available to treat advanced AMD (1) but effectiveness of these advances is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment. For optimal benefit, patients should be able to observe changes in their vision over time. The principal shortcomings of the Amsler grid include periodicity of the test pattern and lack of individual adjustment. For the current study, we have developed several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Mental Stimulation (VMS) grids are hypothesized to facilitate a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features have also been incorporated to allow patients to customize their grid to their particular visual field. In preliminary studies, positive feedback was obtained on initial prototypes from AMD patients and retina specialists. The result will lead to more rapid identification of problems, earlier diagnosis and treatment that will result in fewer people losing their vision. This project will pursue three areas of study: 1 Preparation of paper & electronic prototypes suitable for testing We will continue development of prototypes towards a reliable test tool, formalizing static testing elements and developing dynamic adjustment tools supported by a web-based work-flow logic approach and database. 2 - Comparative study of novel solutions with current prevailing test At the Wilmer Eye Institute of Johns Hopkins University, we will recruit 25 patients (Group 1) with recent onset of unilateral AMD under current care of a retina specialist. The study will compare the results of the novel self-diagnostic VMS tools with current self-monitoring tools (specifically the Amsler grid) over a 6 week period. Current clinical tools (FA, OCT & ICG) will be used to determine a reference baseline. 3 Study to gain feedback of patients' use of tests outside a clinical environment We will recruit two cohorts of 50 patients with recent onset of unilateral AMD under current care of a retina specialist (Group 2, Connecticut cohort) or at risk of AMD (Group 3, Baltimore cohort), and measure their ability to access and utilize the VMS tools without 3rd party support. Patients' success in using the system and their confidence level in results will be ascertained through a questionnaire.

Public Health Relevance:
Age-related macular degeneration (AMD) is the major cause of irreversible legal blindness in the western world. Current self-monitoring tools in patients with AMD fail to adequately indicate pathological vision changes that require immediate attention thus resulting in delayed treatment starts and higher incidences of severe vision loss. Through the application of a novel Visual and Memory Stimulating tool (VMS) this project will improve patients' ability to accurately and confidently self-monitor their AMD between office visits resulting in fewer people losing their vision.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
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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.

Public Health Relevance Statement:
Principal Investigator/Program Director : Roser, Mark Page 3 a) Narrative 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.

Project Terms:
21+ years old; Address; Adherence; Adherence (attribute); Adult; Advertising; Age; Age related macular degeneration; Anti-VEGF; Anti-VEGF Humanized Monoclonal Antibody; Anti-VEGF RhuMAb; Appointment; Au element; Awareness; Awarenesses; Bevacizumab (rhuMAb VEGF); Blindness; Booklets; Books; Brochures; Businesses; Caring; Charge; Clinical Evaluation; Clinical Research; Clinical Study; Clinical Testing; Communication; Compliance behavior; Data; Defect; Diagnosis; Diagnosis, clinical; Disease; Disease Progression; Disorder; Drops; Education; Educational aspects; Effectiveness; Electronics; Elements; Ensure; Evaluation; Eye; Eye Exam; Eye Examination; Eyeball; Feedback; Focus Groups; Fostering; Glass; Gold; Group Interviews; Health Care Professional; Health Insurance for Aged and Disabled, Title 18; Health Insurance for Aged, Title 18; Health Insurance for Disabled Title 18; Health Professional; Health profession; Healthcare professional; Healthcare worker; Hearing; Home; Home environment; Home for seniors; Homes for the Aged; Human, Adult; Individual; Injectable; Internet; Interviews, Group; Knowledge; Learning; Legal patent; Location; Macular degeneration; Macular degenerative disease; Maculopathy, Age-Related; Measures; Medicare; Methods; MoAb VEGF; Monitor; Monoclonal Antibody Anti-VEGF; Newly Diagnosed; Old Age Homes; Ophthalmic examination and evaluation; Outcome; PROV; Pamphlets; Paper; Partial Sight; Patents; Patient Compliance; Patient Cooperation; Patient Education; Patient Instruction; Patient Preferences; Patient Schedules; Patient Training; Patients; Performance; Phase; Population; Preferences, Patient; Principal Investigator; Printing; Programs (PT); Programs [Publication Type]; Provider; QOL; Quality of life; Recombinant Humanized Anti-VEGF Monoclonal Antibody; Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor; Regimen; Reporting; Research Design; Retinal; RhuMAb VEGF; Risk; SCHED; Sales; Schedule; Self Care; Sensitivity and Specificity; Series; Sight; Solutions; Speed; Speed (motion); Spottings; Staging; Study Type; Symptoms; Target Populations; Technology; Testing; Title 18; Treatment Compliance; Variant; Variation; Vision; Vision, Diminished; Vision, Low; Vision, Reduced; Vision, Subnormal; Visit; Visual; Visual Acuity; Visual impairment; WWW; adult human (21+); advanced disease; base; bevacizumab; clinical Diagnosis; clinical test; compliance cooperation; cost; disease/disorder; experience; health insurance for disabled; hearing perception; home for elderly; improved; macula; macular; novel; outreach; patient adherence; patient population; personal care; phase 1 study; programs; prototype; public health relevance; research clinical testing; response; rhuMabVEGF; senile macular disease; socioeconomic; socioeconomically; socioeconomics; sound perception; standard of care; study design; therapy compliance; therapy cooperation; tool; usability; visually impaired; web; web site; world wide web