Age-related macular degeneration (AMD) is the leading cause of visual impairment in developed countries. With an increase in aging population, the prevalence rate of AMD is expected to rise steeply and predicted to reach 288 million globally by 2040. With the advent of anti-VEGF treatments more than a decade ago, significant improvements have been made in managing acute vision loss that occurs in wet AMD. However, there are no treatments currently approved for dry AMD. A major hurdle in the development of novel therapeutics for early AMD is the lack of sensitive endpoints to assess changes in visual function during the early stages of the disease. The goal of Ora’s AMD endpoint program is to develop and validate novel, sensitive visual function endpoints that can identify underlying visual dysfunction during early stages of the disease and thereby can help evaluate therapeutic efficacy of novel AMD therapies.
Ora is currently running an IRB-approved research on over 100 AMD and age-matched normal control subjects over the age of 60. The subjects are screened and evaluated using a battery of tests – 20 distinct tests and 50 variants. In addition, the team has evaluated test-retest reproducibility and repeatability.
Assessing some common tests/endpoints such as ETDRS VA, 2.0 low luminance ETDRS VA, Pelli-Robson Contrast sensitivity test, and MN Read test, it was found that there was no difference between AMD and normal subjects. In contrast, the Ora-VCFTM variable contrast flicker test and Ora’s low luminance tablet reading test show significant visual dysfunction in AMD subjects compared to normal subjects.
Incorporating Ora’s Dry AMD Tests in a Clinical Trial
The Ora-VCFTM test and Ora’s low luminance tablet reading test can be incorporated into your AMD clinical trial as endpoints. Our models can also be used to enrich enrollment to selectively identify subjects with underlying visual dysfunction. They are Part 11 Compliant and our team provides all equipment, installation, and staff training. Continued assistance in test administration ensures success of the model and your trial.