While slowing the growth of geographic atrophy (GA) has become the accepted standard for clinical trial endpoints, experts are now advocating for the inclusion of visual function as a secondary measure. This perspective was shared by Joan W. Miller, MD, chair of ophthalmology at Mass Eye and Ear, during discussions at the AAO meeting.
The Push for Functional Endpoints
Dr. Miller noted a growing interest among specialists to incorporate measures that reflect changes in visual function. "The bar has been set at an anatomic endpoint, so slowing down the growth of GA," Miller stated. "We accept that as specialists, but in the discussion, I think there was a lot of interest in having some other measure — a secondary endpoint that included some change in visual function."
Current Endpoint Standards
Currently, the primary endpoint for many GA clinical trials focuses on anatomical changes, specifically the rate at which GA lesions expand over time. While this endpoint provides an objective measure of disease progression, it may not fully capture the patient's experience of vision loss and functional decline.
Implications for Clinical Trials
The inclusion of visual function endpoints could provide a more comprehensive assessment of treatment benefits, potentially leading to therapies that not only slow disease progression but also improve patients' quality of life. This shift could influence the design of future clinical trials and the evaluation of new treatments for geographic atrophy.
