1:00 Structure Versus Function: Debating the Most Meaningful Endpoints to Drive Regulatory Confidence and Accelerate Dry AMD and Geographic Atrophy Trials
Time: 1:10 pm
day: Pre-Conf Workshop Day
Details:
As clinical development in dry AMD and geographic atrophy accelerates, the field remains divided on how best to define success. Should structural imaging biomarkers take precedence for their
quantifiability, or do functional endpoints better capture what truly matters to patients? While OCT-based metrics like hypertransmission and EZ loss may offer precision, they are unable to reflect visual experience. Meanwhile, functional tests like dark adaptation provide insight into real-world impact-but are often variable, time-consuming, and harder to validate.
This workshop will:
- Host a dynamic debate between leading experts representing structural and functional endpoint perspectives
- Examine the strengths and limitations of current structural markers, including OCT volume-based metrics, autofluorescence, and hypertransmission
- Explore the role of functional endpoints such as dark adaptation, microperimetry, and contrast sensitivity in measuring meaningful patient outcomes
- Discuss regulatory precedent: how have agencies responded to structure vs function in trial submissions, and what’s gaining traction?
