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MACUSTAR SIGNED

Develop and validate appropriate and acceptable outcome measures in intermediate age-related macular degeneration for future interventional clinical trials - Sofia ref.: 116076

Total Cost €

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EC-Contrib. €

0

Partnership

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Project "MACUSTAR" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITATSKLINIKUM BONN 

Organization address
address: VENUSBERG-CAMPUS 1
city: BONN
postcode: 53127
website: www.ukb.uni-bonn.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.macustar.eu
 Total cost 16˙218˙917 €
 EC max contribution 8˙025˙000 € (49%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2015-07-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2017
 Duration (year-month-day) from 2017-09-01   to  2022-08-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITATSKLINIKUM BONN DE (BONN) coordinator 3˙823˙388.00
2    STICHTING KATHOLIEKE UNIVERSITEIT NL (NIJMEGEN) participant 1˙033˙456.00
3    UNIVERSITY COLLEGE LONDON UK (LONDON) participant 782˙987.00
4    FONDATION DE COOPERATION SCIENTIFIQUE VOIR ET ENTENDRE FR (PARIS) participant 760˙639.00
5    MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST UK (LONDON) participant 552˙279.00
6    AIBILI ASSOCIACAO PARA INVESTIGACAO BIOMEDICA E INNOVACAO EM LUZ E IMAGEM PT (COIMBRA) participant 348˙024.00
7    CITY UNIVERSITY OF LONDON UK (LONDON) participant 280˙383.00
8    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 233˙161.00
9    THE UNIVERSITY OF SHEFFIELD UK (SHEFFIELD) participant 210˙679.00
10    BAYER AKTIENGESELLSCHAFT DE (Leverkusen) participant 0.00
11    CARL ZEISS MEDITEC AG DE (JENA) participant 0.00
12    F. HOFFMANN-LA ROCHE AG CH (BASEL) participant 0.00
13    NOVARTIS PHARMA AG CH (BASEL) participant 0.00

Map

 Project 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

 Deliverables

List of deliverables.
ePROM available for selected language versions Other 2020-04-14 16:39:33
6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled across sites) to identify potential training needs - 4 Documents, reports 2020-04-14 16:39:34
6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled across sites) to identify potential training needs - 3 Documents, reports 2020-04-14 16:39:34
Statistical Analysis Plan – Cross-Sectional Part Documents, reports 2020-04-14 16:39:34
PROM/ePROM administration guidelines available Documents, reports 2020-04-14 16:39:33
PROM delivered for translation Other 2020-04-14 16:39:33
Itemisation of functional assessment parameters in the cross-sectional part and longitudinal part of the MACUSTAR study Documents, reports 2020-04-14 16:39:33
Press release – project start Websites, patent fillings, videos etc. 2020-04-14 16:39:33
Launch of website Websites, patent fillings, videos etc. 2020-04-14 16:39:33
6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled across sites) to identify potential training needs - 2 Documents, reports 2020-04-14 16:39:33
First study subject approvals package Documents, reports 2020-04-14 16:39:33
Registration of MACUSTAR clinical study in clinical trials.gov Documents, reports 2020-04-14 16:39:33
SOPs for all functional tests Documents, reports 2020-04-14 16:39:33

Take a look to the deliverables list in detail:  detailed list of MACUSTAR deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Cecília V. Martinho, Daniel Sanches Fernandes
European Network of Clinical Research in Ophthalmology Information Update – December 2018
published pages: 183-187, ISSN: 0030-3747, DOI: 10.1159/000496497
Ophthalmic Research 61/4 2020-04-14
2019 Jan H. Terheyden, Robert P. Finger, Steffen Schmitz-Valckenberg, Hansjürgen Agostini, Claudia Dahlke, Laura Kuehlewein, Gabriele E. Lang, Daniel Pauleikhoff, Armin Wolf, Michael K. Boettger, Ulrich F. O. Luhmann, Friedrich Asmus, Frank G. Holz
MACUSTAR: Entwicklung und klinische Validierung von funktionellen, strukturellen und patientenberichteten Endpunkten bei intermediärer altersabhängiger Makuladegeneration
published pages: , ISSN: 0941-293X, DOI: 10.1007/s00347-019-0907-1
Der Ophthalmologe 2020-04-14
2019 Hannah Dunbar; Ariel Zenouda; Saddek Mohand-Saïd; Jose Alain Sahel; Gary S Rubin
The effect of illumination on mobility performance in patients with Age-related Macular Degeneration: A pilot study
published pages: , ISSN: , DOI:
ARVO Annual Meeting Abstracts 1 2020-04-14
2017 Frank G. Holz
Development of Novel Clinical Endpoints in Intermediate AMD (MACUSTAR)
published pages: NCT number: NCT0, ISSN: , DOI:
ClinicalTrials.gov 2020-04-14
2018 Robert P. Finger, Steffen Schmitz-Valckenberg, Matthias Schmid, Gary S. Rubin, Hannah Dunbar, Adnan Tufail, David P. Crabb, Alison Binns, Clara I. Sánchez, Philippe Margaron, Guillaume Normand, Mary K. Durbin, Ulrich F.O. Luhmann, Parisa Zamiri, José Cunha-Vaz, Friedrich Asmus, Frank G. Holz
MACUSTAR: Development and Clinical Validation of Functional, Structural, and Patient-Reported Endpoints in Intermediate Age-Related Macular Degeneration
published pages: 1-12, ISSN: 0030-3755, DOI: 10.1159/000491402
Ophthalmologica 2020-04-14

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