MACUSTAR extends Europe-wide clinical study on intermediate age-related macular degeneration

University Hospital of Bonn (UKB)Feb 2 2024

The MACUSTAR consortium is extending the duration of a Europe-wide clinical study on age-related macular degeneration (AMD) under the coordination of the Department of Ophthalmology at the University Hospital Bonn (UKB). The focus is on gathering further insights on the intermediate form of the disease, which progresses to late-stage manifestations associated with visual loss.

In age-related macular degeneration (AMD), photoreceptors in the center of sharpest vision gradually degenerate, potentially leading to vision loss. The disease mainly affects individuals over the age of 60 years. Due to increasing life expectancy, the number of people affected continues to rise. AMD progresses from an early to an intermediate stage to a late stage, which can lead to severe loss of vision and blindness.

There is an urgent need to develop new therapies that slow or halt the progression from intermediate to late AMD. In order for new therapeutic approaches to be tested in clinical trials, methods must first be developed and biomarkers identified to reliably determine efficacy."

Prof. Dr. Frank G. Holz, Director of the UKB Department of Ophthalmology

At the heart of MACUSTAR is an observational study with 585 patients with intermediate AMD, in which 20 clinical study centers across seven European countries are participating. The study is investigating which exams are predictive of disease progression and therefore represent potential endpoints for future interventional trials in iAMD. These exams include high-resolution imaging technologies, a detailed set of functional tests as well as instruments to evaluate patient-reported outcomes. In addition to conventional visual function tests, vision in poor light conditions and different contrast settings are also assessed. Examinations of the ability to adapt to dark vision, reading speed as well as navigation performance are expected to provide further information about the impact of the progression of this disease in visual function.

This is the largest systematic study on intermediate AMD to date. The aim of the MACUSTAR consortium is to find out which parameters or which combination of different markers provides the best approach to test new therapeutic strategies to be accepted by the regulatory authorities. "The evaluation of the baseline and 3-year follow-up data has already led to significant new advances in knowledge, with regard to the heterogeneity and prognostic factors of the disease", explains Prof. Dr. Robert Finger. The extension of this study is expected to strengthen the understanding of how AMD evolves over time, enabling earlier detection of progression and facilitating development of innovative treatments in the future.

The MACUSTAR consortium receives a grant of 16.2 million euros from the Innovative Medicines Initiative 2 Joint Undertaking, supported by the European Union's Horizon 2020 Framework Program for Research and Innovation and EFPIA. Recently, the industry partners Bayer, Novartis and Roche have agreed to a further €3 million grant in order to extend the study by an additional three years.
To date, the MACUSTAR results have been reported across 26 peer-reviewed publications.

The consortium

The UKB Eye Hospital, GRADE Reading Center Bonn, the Moorfields Eye Hospital London (MBRC), University College London (UCL), the City University of London (City) and the Fondation Voir et Entendre (FVE) Paris, the Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, the Radboud University Medical Center (RUMC) Nijmegen, the University of Sheffield and the European Clinical Research Infrastructures Network (ECRIN) Paris as well as the companies Carl Zeiss-Meditec, Bayer AG, Novartis Pharma AG and F. Hoffmann La-Roche.