MACUSTAR - Intermediate AMD: Development of Novel Clinical Endpoints for Clinical Trials in Patients with a Regulatory and Patient Access Intention

Overview

Project Summary

Age-related macular degeneration (AMD) is the commonest cause of severe visual loss and blindness in Europe and affects almost 30 percent of the older population. The chronic disease progresses slowly from early AMD to intermediate AMD (iAMD) and ultimately late-stage AMD with severe and frequently irreversible visual loss of central vision. MACUSTAR stands for a unique research approach: In an observational clinical study with 20 participating clinical study sites all over Europe 750 affected patients will be recruited and reviewed for a period of up to five years. One part of the study concentrates on the different stages of AMD (early, intermediate, late; and no AMD). The second part of the study examines the progression from intermediate AMD to late stage AMD against the functional, morphological, and patient-reported alterations. The study data is analyzed to develop and validate appropriate clinical endpoints for future clinical trials and drug development in iAMD.

Main Goals

The objectives of MACUSTAR are to characterize the functional deficit in iAMD and to develop and validate functional, structural and patient reported outcome measures for iAMD. In addition, risk factors for progression from iAMD to late AMD will be investigated.

Project Details