Currently, no outcome measures have been validated and accepted as clinical endpoints by regulatory agencies for drug development in intermediate age-related macular degeneration (iAMD). The MACUSTAR Consortium, a public-private research group funded by the European Innovative Medicines Initiative (EIMI), intends to close this gap.
The European MACUSTAR consortium is conducting a three-year observational study of 750 patients with AMD, consisting mainly of subjects with iAMD (n=600). Participants will be recruited by 20 participating clinical trial centres in seven European countries.
The aim of the research is to identify variables that provide reliable information on disease progression or stability, which could then be further developed into clinical tests.
The study rationale and protocol has recently been published in the journal Opthalmologica.
The MACUSTAR consortium currently comprises 15 members including the University of Bonn, Germany; Moorfields Eye Hospital London; Fondation Voir et Entendre, Paris; and the European Clinical Research Infrastructures Network (ECRIN), as well as the companies Bayer AG, Novartis Pharma AG, Carl Zeiss-Meditec and F. Hoffmann La-Roche.
The project has received funding of €16 million from the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU), supported by the Horizon 2020 European Union Research and Innovation Framework Program and the European Federation of Pharmaceutical Industries and Associations.