Overview
Age-related macular degeneration (AMD) is a major cause of sight loss. It gets worse over time and about 4 in 10 people develop late-stage ‘dry’ AMD.
Several treatments have been tried for AMD, but they may have been given too late to save sight because there hasn’t been a reliable way to monitor the early stages. So we need to develop better ways of measuring people’s vision in both bright and low light. (The light-detecting ‘photoreceptor’ cells that work in low light are affected earlier than the bright light cells.) We also need to be able to pick up smaller changes to vision as well as to find a way to measure changes that can’t be picked up by a sight test alone.
In this project, the research team is trying out a new sight test, in bright and low light, with people who have early AMD, late-stage dry AMD and Stargardt macular degeneration. The team is also using a patient-friendly laser scanner to find out how closely packed the photoreceptors we use in bright light are. They will match up people’s sight test results with what the laser scan shows. They will also compare the new test results with results from conventional tests to find out how reliable the new test is.
Results from the study should help with earlier diagnosis, better monitoring of how AMD is progressing, better ways to measure the effect of potential treatments and perhaps new clinical guidelines on how to diagnose and follow-up on people with AMD.
-
Scientific summary
Developing and validating endpoints for clinical trials for early and late dry AMD
Current endpoints for dry AMD trials (high contrast central acuity - used by EMA, FDA) or change in geographic atrophy area (FDA) are limited by insufficient sensitivity in early stage disease and variability in methods for lesion size measurement in advanced stages. Given the slow disease progression before central visual loss, the team is aiming to develop novel validated endpoints to confirm visual loss at an earlier stage, accelerate and cost-reduce clinical trials and allow for better evaluation of interventions that have the potential to stop or slow disease progression before advanced atrophy develops.