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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

MACUSTAR project word cloud

Explore the words cloud of the MACUSTAR project. It provides you a very rough idea of what is the project "MACUSTAR" about.

regards outcome despite macustar delaying progression accepted clinical burden demographic disease reported preceding nor bodies regulatory morphological irreversible hta age continues validated amd cts risk exist endpoint acceptable visual impacts unknown decline structural patients functional impairment interventions function stage conduct stopping prerequisite degeneration endpoints reliably patient good quantified treatment prevalence additional inform intention life indicating background population severe agencies health iamd extend trials rapid measured intermediate macular reduce clinically payers stages successful incidence

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 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.	DE (BONN)	coordinator	3˙823˙388.00
2	STICHTING KATHOLIEKE UNIVERSITEIT STICHTING KATHOLIEKE UNIVERSITEIT Organization address address: GEERT GROOTEPLEIN NOORD 9 city: NIJMEGEN postcode: 6525 EZ website: www.radboudumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (NIJMEGEN)	participant	1˙033˙456.00
3	UNIVERSITY COLLEGE LONDON UNIVERSITY COLLEGE LONDON Organization address address: GOWER STREET city: LONDON postcode: WC1E 6BT website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	782˙987.00
4	FONDATION DE COOPERATION SCIENTIFIQUE VOIR ET ENTENDRE FONDATION DE COOPERATION SCIENTIFIQUE VOIR ET ENTENDRE Organization address address: 17 RUE MOREAU city: PARIS postcode: 75012 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	760˙639.00
5	MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST Organization address address: City Road 162 city: LONDON postcode: EC1V 2PD website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	552˙279.00
6	AIBILI ASSOCIACAO PARA INVESTIGACAO BIOMEDICA E INNOVACAO EM LUZ E IMAGEM AIBILI ASSOCIACAO PARA INVESTIGACAO BIOMEDICA E INNOVACAO EM LUZ E IMAGEM Organization address address: Azinhaga de Santa Comba, Celas city: COIMBRA postcode: 3000 548 website: www.aibili.pt contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PT (COIMBRA)	participant	348˙024.00
7	CITY UNIVERSITY OF LONDON CITY UNIVERSITY OF LONDON Organization address address: NORTHAMPTON SQUARE city: LONDON postcode: EC1V 0HB website: www.city.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	280˙383.00
8	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	233˙161.00
9	THE UNIVERSITY OF SHEFFIELD THE UNIVERSITY OF SHEFFIELD Organization address address: FIRTH COURT WESTERN BANK city: SHEFFIELD postcode: S10 2TN website: www.shef.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SHEFFIELD)	participant	210˙679.00
10	BAYER AKTIENGESELLSCHAFT BAYER AKTIENGESELLSCHAFT Organization address address: KAISER-WILHEM-ALLEE 1 city: Leverkusen postcode: 51373 website: http://pharma.bayer.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (Leverkusen)	participant	0.00
11	CARL ZEISS MEDITEC AG CARL ZEISS MEDITEC AG Organization address address: GOSCHWITZER STRASSE 51-52 city: JENA postcode: 7745 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (JENA)	participant	0.00
12	F. HOFFMANN-LA ROCHE AG F. HOFFMANN-LA ROCHE AG Organization address address: GRENZACHERSTRASSE 124 city: BASEL postcode: 4070 website: www.roche.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
13	NOVARTIS PHARMA AG NOVARTIS PHARMA AG Organization address address: LICHTSTRASSE 35 city: BASEL postcode: 4056 website: www.novartis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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 â€“ 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 â€“ 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

List of publications.
year	authors and title	journal	last update
2019	CecÃliaÂ V. Martinho, Daniel SanchesÂ Fernandes European Network of Clinical Research in Ophthalmology Information Update â€“ 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, HansjÃ¼rgen 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 intermediÃ¤rer altersabhÃ¤ngiger 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-SaÃ¯d; 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	RobertÂ P. Finger, Steffen Schmitz-Valckenberg, Matthias Schmid, GaryÂ S. Rubin, Hannah Dunbar, Adnan Tufail, DavidÂ P. Crabb, Alison Binns, ClaraÂ I. SÃ¡nchez, Philippe Margaron, Guillaume Normand, MaryÂ K. Durbin, UlrichÂ F.O. Luhmann, Parisa Zamiri, JosÃ© Cunha-Vaz, Friedrich Asmus, FrankÂ 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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