Intermediate age-related macular degeneration (iAMD) patients are at risk of progression to late stage AMD with even more severe impairment of vision and potentially legal blindness. Currently, there is no therapeutic intervention to delay or stop this progression to late stage AMD. Although the more common late neovascular or wet AMD can be treated with intravitreal anti-VEGF injections, it remains a vision threatening disease (e.g. due to subretinal hemorrhages or atrophy and fibrosis development).In order to reduce the significant burden of late AMD, novel interventions that stop or delay progression from iAMD to late AMD will need to be developed. The successful development of iAMD interventions requires validated functional, morphological and patient-reported endpoints for clinical trials which are clinically meaningful and accepted by regulatory agencies.
The major objective of MACUSTAR is to develop novel clinical endpoints for CTs with a regulatory and patient access intention in patients with iAMD. Particularly, this project focuses on the identification of structural biomarkers with regards to disease progression and of structural surrogate markers for functional impairment of vision in iAMD patients based on multimodal image analysis using artificial intelligence. This project is is supported by the Innovative Medicines Initiative (IMI) and complemented by an in-kind and in-cash contribution by EFPIA partners and ZEISS Meditec AG.