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EU funding (€8,025,000): Develop and validate appropriate and acceptable outcome measures in intermediate age-related macular degeneration for future interventional clinical trials - Sofia ref … Hor1 Sept 2017 EU Research and Innovation programme "Horizon"

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Develop and validate appropriate and acceptable outcome measures in intermediate age-related macular degeneration for future interventional clinical trials - Sofia ref.: 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


Funded Companies:

Company name Funding amount
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

Source: https://cordis.europa.eu/project/id/116076

The filing refers to a past date, and does not necessarily reflect the current state.

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