Suchergebnisse

Hintergrund Für Therapiestudien bei intermediärer altersabhängiger Makuladegeneration (iAMD) gibt es bislang keine validierten klinischen Endpunkte. Ziel der Arbeit Die europäische MACUSTAR-Studie hat zum Ziel, adäquate klinische Endpunkte für Therapiestudien bei iAMD zu entwickeln und klinisch zu validieren. Von besonderem Interesse ist es, Faktoren zu identifizieren, welche eine Progression der intermediären zur späten AMD frühzeitig anzeigen. Material und Methoden Das MACUSTAR-Studienprotokoll wurde von einem internationalen Konsortium von Forschern aus Wissenschaft und Pharmaindustrie/Medizingeräteherstellern entwickelt. Das MACUSTAR-Projekt wird von der Innovative Medicines Initiative 2 (IMI2) der Europäischen Union gefördert. Ergebnisse Die MACUSTAR-Studie besteht aus einer Querschnitts- und einer Längsschnittuntersuchung. Insgesamt werden 750 Probanden mit früher, intermediärer und später AMD sowie Probanden ohne AMD in 20 europäischen Studienzentren rekrutiert, und der AMD-Verlauf wird über einen Zeitraum von 3 Jahren verfolgt. Diskussion Mit dem MACUSTAR-Projekt besteht die Möglichkeit, neue Endpunkte für Interventionsstudien bei intermediärer AMD mit großen Datensätzen in hoher Qualität klinisch zu validieren. Dies geschieht mit dem Ziel, dass diese Endpunkte von den zuständigen Behörden als für Arzneimittelzulassungsstudien geeignet akzeptiert werden und der Verlauf der Erkrankung besser charakterisiert wird. ; Name of action: Intermediate AMD: Development of novel clinical endpoints for clinical trials in patients with a regulatory and patient access intention - MACUSTAR This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. The article was first published in Der Ophthalmologe. The final publication is available at http://link.springer.com.

Background Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Background. Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective. The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods. The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results. The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion. The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.