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Intermediate AMD: Development of novel clinical endpoints for clinical trials in patients with a regulatory and patient access intention 



Prof. Dr. Frank G. Holz
Prof. Dr. Dr. Robert Finger
Universitäts-Augenklinik Bonn
Universitätsklinikum Bonn
Ernst-Abbe-Straße 2
53127 Bonn
E-Mail: [Email protection active, please enable JavaScript.]

Laufzeit: 01.09.2017 - 31.08.2022


People with dry age-related macular degeneration (AMD) gradually lose their central vision, usually in both eyes. It is already a leading cause of blindness worldwide, and as the population ages, the number of cases is likely to rise. There is currently no effective treatment for dry AMD. One barrier to the development of new treatments is the lack of tests capable of determining the effectiveness of treatments under development. Put simply, current tests do not detect all of the sight problems experienced by people with earlier stages of the disease (e.g. intermediate AMD).
The goal of the MACUSTAR project is to develop and validate tests that are capable of accurately detecting subtle changes in the disease over time. The project will follow more than 700 AMD patients over 3 years through tests including state-of-the-art imaging techniques and vision testing, as well as patient-reported outcome measures that capture the impact of the disease on patients’ quality of life. The hope is that these methods will prove capable of detecting changes in the patients’ disease. The team also hopes to shed new light on visual impairment in intermediate AMD and its progression, as well as the risk factors that cause the disease to progress faster in some patients than others.
By developing and validating new methods to study disease progression in dry AMD, the overall goal of MACUSTAR is to help drug development and make clinical trials of potential treatments more efficient.

Project website: www.macustar.eu


EFPIA companies

  • Bayer Aktiengesellschaft, Leverkusen, Germany (Project Leader)
  • F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Novartis Pharma AG, Basel, Switzerland

Further industry partner

  • Carl Zeiss Meditec AG, Jena, Germany

Universities, research organisations

  • Universitaetsklinikum Bonn, Bonn, Germany (Coordinator)
  • AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal
  • City, University of London, London, United Kingdom
  • European Clinical Research Infrastructure Network (ECRIN-ERIC), Paris, France
  • Fondation Voir et Entendre, Paris, France
  • Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom
  • Radboud University Medical Center, Nijmegen, Netherlands