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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

Coordinator

UNIVERSITATSKLINIKUM BONN
Net EU contribution
€ 4 128 761,48
Address
Venusberg-campus 1
53127 Bonn
Germany

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Region
Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 284 686,17

Participants (18)

BAYER AKTIENGESELLSCHAFT
Germany
Net EU contribution
€ 0,00
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen

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Region
Nordrhein-Westfalen Köln Leverkusen, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 637 711,00
MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 361 902,52
Address
City Road 162
EC1V 2PD London

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Region
London Inner London — East Haringey and Islington
Activity type
Research Organisations
Other funding
€ 11 955,62
NOVARTIS PHARMA AG
Switzerland
Net EU contribution
€ 0,00
Address
Lichtstrasse 35
4056 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 049 553,38
AIBILI ASSOCIACAO PARA INVESTIGACAO BIOMEDICA E INNOVACAO EM LUZ E IMAGEM
Portugal
Net EU contribution
€ 663 137,58
Address
Azinhaga De Santa Comba, Celas
3000 548 Coimbra

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Region
Continente Centro (PT) Região de Coimbra
Activity type
Research Organisations
Other funding
€ 3 317 812,60
CITY UNIVERSITY OF LONDON
United Kingdom
Net EU contribution
€ 245 632,23
Address
Northampton Square
EC1V 0HB London

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Region
London Inner London — East Haringey and Islington
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 185 045,51
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 107 399,76
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 25 010,93
Address
3 Avenue Victoria
75000 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSIDADE NOVA DE LISBOA
Portugal
Net EU contribution
€ 60 650,00
Address
Campus De Campolide
1099 085 Lisboa

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Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Higher or Secondary Education Establishments
Other funding
€ 26 551,10
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 38 486,63
Address
Alt-moabit 96 A
10559 Berlin

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Region
Berlin Berlin Berlin
Activity type
Research Organisations
Other funding
€ 12 574,37
FONDATION DE COOPERATION SCIENTIFIQUE VOIR ET ENTENDRE
France
Net EU contribution
€ 20 896,43
Address
17 Rue Moreau
75012 Paris

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Region
Ile-de-France Ile-de-France Val-de-Marne
Activity type
Research Organisations
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Streetlab
France
Net EU contribution
€ 89 506,88
Address
17 Rue Moreau
75012 Paris

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ile-de-France Ile-de-France Val-de-Marne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 3 061,73
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CENTRE HOSPITALIER NATIONAL D'OPHTALMOLOGIE DES QUINZE-VINGTS
France
Net EU contribution
€ 416 705,21
Address
Rue De Charenton 28
75571 Paris Cedex 12

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Region
Ile-de-France Ile-de-France Paris
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 34 312,75
F. HOFFMANN-LA ROCHE AG
Switzerland
Net EU contribution
€ 0,00
Address
Grenzacherstrasse 124
4070 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 135 000,00
STICHTING RADBOUD UNIVERSITEIT

Participation ended

Netherlands
Net EU contribution
€ 0,00
Address
Houtlaan 4
6525 XZ Nijmegen
Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
THE UNIVERSITY OF SHEFFIELD
United Kingdom
Net EU contribution
€ 210 679,00
Address
Firth Court Western Bank
S10 2TN Sheffield

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Region
Yorkshire and the Humber South Yorkshire Sheffield
Activity type
Higher or Secondary Education Establishments
Other funding
€ 5 736,28
UNIVERSITY COLLEGE LONDON
United Kingdom
Net EU contribution
€ 782 987,12
Address
Gower Street
WC1E 6BT London

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Other funding
€ 152 563,21
CARL ZEISS MEDITEC AG
Germany
Net EU contribution
€ 0,00
Address
Goschwitzer Strasse 51-52
07745 Jena

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Region
Thüringen Thüringen Jena, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 415 000,00
STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands
Net EU contribution
€ 795 598,48
Address
Geert Grooteplein 10 Zuid
6525 GA Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00