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Financement de l’UE (8 025 000 €) : Développer et valider des mesures de résultats appropriées et acceptables dans la dégénérescence maculaire liée à l’âge intermédiaire pour de futurs essais … Hor 01/09/2017 Programme de recherche et d'innovation de l'UE « Horizon »
Texte
Développer et valider des mesures de résultats appropriées et acceptables dans la dégénérescence maculaire liée à l’âge intermédiaire pour de futurs essais cliniques interventionnels - Sofia réf. : 116076
Despite significant advances in the treatment and understanding of late stage age-related macular degeneration (AMD), it continues to be the main cause of irreversible severe visual loss in Europe and its prevalence and incidence will increase with current demographic trends. In order to reduce the significant burden of late stage AMD, novel interventions should aim at stopping or delaying progression from the preceding disease stage intermediate AMD (iAMD) to late stage AMD. As a prerequisite, validated clinical endpoints for iAMD are needed. These should be acceptable to regulatory agencies, health technology assessment (HTA) bodies, and payers. Currently such endpoints do not exist for iAMD clinical trials (CTs). In addition, there is good evidence indicating that patients with iAMD experience some impairment of visual function yet it is unknown to what extend this impacts the patients’ life nor can it be reliably measured and quantified. It is also unknown whether there are specific risk factors in the population of iAMD patients which identify those with more rapid progression to late stages of the disease. Therefore, to enable successful development of iAMD interventions validated functional, morphological and patient--reported endpoints for CTs, which are clinically meaningful and accepted by regulatory agencies, are required. In addition, functional decline in iAMD, as well as, specific risk factors for iAMD progression to late stage AMD need to be better characterized to inform and improve conduct of future iAMD CTs. Against this background, the major objective of MACUSTAR is to develop novel clinical endpoints for CTs with a regulatory and patient access intention in patients with iAMD. Additional objectives are to characterize visual impairment in iAMD and its progression, as well as, identify risk factors for progression. For clinical endpoint development, functional, structural and patient-reported outcome measures will be assessed with regards to
| Aibili Associação para Investigacao Biomedica e Innovacao em Luz e Imagem | 833 968 € |
| Assistance Publique Hopitaux de Paris | 0,00 € |
| Bayer AG | 0,00 € |
| Carl Zeiss Meditec AG | 0,00 € |
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | 0,00 € |
| City St Georges University of London | 280 383 € |
| Ecrin European Clinical Research Infrastructure Network | 367 836 € |
| F. Hoffmann-LA Roche AG | 0,00 € |
| Fondation de Cooperation Scientifique Voir et Entendre | 517 084 € |
| KKS-Netzwerk e. V. -Netzwerk DER Koordinierungszentren FUR Klinische Studien | 0,00 € |
| Moorfields EYE Hospital NHS Foundation Trust | 361 903 € |
| Novartis Pharma AG | 0,00 € |
| Stichting Radboud Universitair Medisch Centrum | 805 623 € |
| Stichting Radboud Universiteit | 0,00 € |
| Streetlab | 0,00 € |
| The University of Sheffield | 210 679 € |
| Universidade Nova de Lisboa | 0,00 € |
| Universitatsklinikum Bonn | 3 802 893 € |
| University College London | 844 631 € |
https://cordis.europa.eu/project/id/116076
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.