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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

Objective

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

Call for proposal

H2020-JTI-IMI2-2015-07-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

UNIVERSITATSKLINIKUM BONN
Address
Venusberg-campus 1
53127 Bonn
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 3 823 388,91

Participants (12)

BAYER AKTIENGESELLSCHAFT
Germany
EU contribution
€ 0
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 552 279,96
Address
City Road 162
EC1V 2PD London
Activity type
Research Organisations
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 0
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
AIBILI ASSOCIACAO PARA INVESTIGACAO BIOMEDICA E INNOVACAO EM LUZ E IMAGEM
Portugal
EU contribution
€ 348 024,21
Address
Azinhaga De Santa Comba, Celas
3000 548 Coimbra
Activity type
Research Organisations
CITY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 280 383,13
Address
Northampton Square
EC1V 0HB London
Activity type
Higher or Secondary Education Establishments
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 233 161,63
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
FONDATION DE COOPERATION SCIENTIFIQUE VOIR ET ENTENDRE
France
EU contribution
€ 760 639,97
Address
17 Rue Moreau
75012 Paris
Activity type
Research Organisations
F. HOFFMANN-LA ROCHE AG
Switzerland
EU contribution
€ 0
Address
Grenzacherstrasse 124
4070 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STICHTING KATHOLIEKE UNIVERSITEIT
Netherlands
EU contribution
€ 1 033 456,07
Address
Geert Grooteplein Noord 9
6525 EZ Nijmegen
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF SHEFFIELD
United Kingdom
EU contribution
€ 210 679
Address
Firth Court Western Bank
S10 2TN Sheffield
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 782 987,12
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
CARL ZEISS MEDITEC AG
Germany
EU contribution
€ 0
Address
Goschwitzer Strasse 51-52
07745 Jena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)