Personalized Monitoring of Early and Intermediate Age-related Macular Degeneration Using Artificial Intelligence to Identify Disease Progression in a Multinational Observational Study

What this Trial Is About

Researchers are conducting a prospective, multinational, multicenter observational study to predict the progression from early and intermediate age-related macular degeneration AMD with functional vision to advanced AMD that causes irreversible vision loss over two years. The study aims to identify and measure specific changes in the retina related to disease progression, assess individual risk of advancing to severe AMD using imaging, clarify the sequence of events leading to advanced AMD, and improve AMD classification by using artificial intelligence alongside traditional methods. Participants will be monitored for 24 months with visits every six months. During these visits, researchers will perform non-invasive imaging tests including scanning laser fundus photography, color fundus photography, optical coherence tomography, and optical coherence tomography angiography. Participants will also provide medical history and complete standard eye exams and questionnaires about their vision. No treatments will be given as part of the study since no approved treatment is currently available in Europe, but if treatments become approved, patients may receive them as part of their usual care outside the study. Throughout the study, investigators will track retinal changes and disease progression using imaging and questionnaires. The main outcome is to characterize retinal alterations to identify patients at risk of developing advanced AMD. Secondary outcomes include identifying biomarkers of disease progression and evaluating the use of AI to monitor AMD. Safety and standard care will be maintained, and participants will be followed closely to understand AMD progression over time.

Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression