Develop and validate appropriate and acceptable outcome measures in intermediate age-related macular degeneration for future interventional clinical trials - Sofia ref.: 116076 | MACUSTAR | Project | Results | H2020 | CORDIS

Deliverables

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 - 8

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

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 - 5

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

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 - 7

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

SOPs for all functional tests

Migration

Statistical Analysis Plan – Cross-Sectional Part

Migration

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

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

PROM/ePROM administration guidelines available

Migration

First study subject approvals package

Migration

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

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

Results report for functional tests incorporated in cross- sectional part of CS results

Migration

Itemisation of functional assessment parameters in the cross-sectional part and longitudinal part of the MACUSTAR study

Migration

Registration of MACUSTAR clinical study in clinical trials.gov

Migration

Study Report cross-sectional part

Migration

Measurement characteristics of PROM assessed and manuscript drafted

Migration

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 - 9

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

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 - 6

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

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

6 monthly evaluation of functional data across sites (distribution of data, examination of raw data from individuals sampled

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, extension 1

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

PROM delivered for translation

Migration

ePROM available for selected language versions

Migration

Model combining structural and functional measurements

Migration

Press release – project start

Migration

Launch of website

Migration

Publications

Inter-reader repeatability of structural biomarkers in age-related macular degeneration in the multi-center MACUSTAR study

Author(s): Marlene Sassmannshausen; Maximilian Pfau; Sarah Thiele; Charlotte Behning; Matthias Schmid; Frank G Holz; Steffen Schmitz-Valckenberg
Published in: ARVO Annual Meeting Abstracts, Issue 1, 2021
Publisher: Association for Research in Vision and Ophthalmology

Multiple clinical vision tests reveal heterogeneous deficits in intermediate AMD.

Author(s): Hannah Dunbar, David P. Crabb, Charlotte Behning, Jan H. Terheyden, Alison M. Binns, Stephen Poor, Ulrich F. O. Luhmann
Published in: Ophthalmologica 2021;244:1–1087, Issue Euretina 2021 Virtual Abstracts, 2021
Publisher: S. Karger AG

MACUSTAR cross-sectional data: Repeatability and discriminatory power of visual function tests

Author(s): Hannah M P Dunbar; Charlotte Behning; Deanna J Taylor; Bethany Elora Higgins; Giovanni Montesano; Alison Binns; Jan Henrik Terheyden; Amina Abdirahman; Nadia Zakaria; Stephen Poor; Gary S Rubin; Matthias Schmid; David P. Crabb; Ulrich F O Luhmann
Published in: ARVO Annual Meeting Abstracts, Issue 1, 2021
Publisher: Association for Research in Vision and Ophthalmology

Psychometric properties of the Vision Impairment in Low Luminance (VILL) questionnaire in age-related macular degeneration in the MACUSTAR study

Author(s): Jan Henrik Terheyden; Susanne Gunda Pondorfer; Charlotte Behning; Moritz Berger; Donna Rowen; Jill Carlton; Frank G Holz; Thomas Butt; John E. Brazier; Robert Patrick Finger
Published in: ARVO Annual Meeting Abstracts, Issue 1, 2021
Publisher: Association for Research in Vision and Ophthalmology

The impact of luminance and disease stage on navigation performance in age related macular degeneration (AMD): A MACUSTAR study report.

Author(s): Ariel Zenouda; Alina Schenk; Amina Abdirahman; Charlotte Behning; José-Alain Sahel; Adnan Tufail; Nadia Zakaria; Nick Tyler; Saddek Mohand-Said; Michel Paques; Ulrich F O Luhmann; Hannah M P Dunbar
Published in: Investigative Ophthalmology & Visual Science, June 2022, Vol.63, 880, Issue annual: Special issue ARVO Abstract issue, 2022
Publisher: ARVO Journals

The effect of illumination on mobility performance in patients with Age-related Macular Degeneration: A pilot study

Author(s): Hannah Dunbar; Ariel Zenouda; Saddek Mohand-Saïd; Jose Alain Sahel; Gary S Rubin
Published in: ARVO Annual Meeting Abstracts, Issue 1, 2019
Publisher: Association for Research in Vision and Ophthalmology

Inter-device and inter-scan comparability of drusen volume assessments in age-related macular degeneration: A MACUSTAR report

Author(s): Davide Garzone; Robert P Finger; Olivier Morelle; Maximilian W M Wintergerst; Marlene Sassmannshausen; Steffen Schmitz-Valckenberg; Maximilian Pfau; Sarah Thiele; Stephen Poor; Sergio Leal; Frank G Holz; Jan Henrik Terheyden
Published in: Investigative Ophthalmology & Visual Science, June 2022, Vol.63, 880, Issue annual: Special issue ARVO Abstract issue, 2022
Publisher: ARVO Journals

Comparison of visual function in structurally defined sub-phenotypes of intermediate AMD: A MACUSTAR study report.

Author(s): Hannah M P Dunbar; Marlene Sassmannshausen; Charlotte Behning; Sarah Thiele; Alison Binns; Bethany Elora Higgins; Jan Henrik Terheyden; Adnan Tufail; Sergio Leal; Nadia Zakaria; Frank G Holz; Matthias C Schmid; Robert P Finger; David P. Crabb; Steffen Schmitz-Valckenberg; Ulrich F O Luhmann
Published in: Investigative Ophthalmology & Visual Science, June 2022, Vol.63, 880, Issue annual: Special issue ARVO Abstract issue, 2022
Publisher: ARVO Journals

Relative ellipsoid zone reflectivity and age-related macular degeneration severity in the MACUSTAR study.

Author(s): Sarah Thiele, Charlotte Behning, Marlene Saßmannshausen, Matthias Schmid, Frak G. Holz, Steffen Schmitz-Valckenberg, Maximilian Pfau
Published in: Ophthalmologica 2021;244:1–1087, Issue Euretina 2021 Virtual Abstracts, 2021
Publisher: S. Karger AG

Patient-reported low-luminance impairment in intermediate age-related macular degeneration corresponds with visual function in the MACUSTAR study.

Author(s): Jan H. Terheyden, Hannah Dunbar, Charlotte Behning, David Crabb, Stephen Poor, Ulrich F.O. Luhmann, Robert P. Finger
Published in: Ophthalmologica 2021;244:1–1087, Issue Euretina 2021 Virtual Abstracts, 2021
Publisher: S. Karger AG

Reliability of structural biomarkers between sessions and readers in age-related macular degeneration in the multi-center MACUSTAR study.

Author(s): Marlene Saßmannshausen, Maximilian Pfau, Sarah Thiele, Charlotte Behning, Matthias Schmid, Frank G. Holz, Steffen Schmitz-Valckenberg
Published in: Ophthalmologica 2021;244:1–1087, Issue Euretina 2021 Virtual Abstracts, 2021
Publisher: S. Karger AG
DOI: 10.1159/000519205

Characteristics and Spatial Distribution of Structural Features in Age-Related Macular Degeneration: A MACUSTAR Study Report

Author(s): Marlene Saßmannshausen, Charlotte Behning, Jonas Weinz, Lukas Goerdt, Jan H. Terheyden, Petrus Chang, Matthias Schmid, Stephen H. Poor, Nadia Zakaria, Robert P. Finger, Frank G. Holz, Maximilian Pfau, Steffen Schmitz-Valckenberg, Sarah Thiele
Published in: Ophthalmology Retina, 2023, ISSN 2468-6530
Publisher: American Academy of Ophthalmology
DOI: 10.1016/j.oret.2022.12.007

Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

Author(s): Jan Henrik Terheyden, Charlotte Behning, Anna Lüning, Ludmila Wintergerst, Pier G. Basile, Diana Tavares, Beatriz A. Melício, Sergio Leal, George Weissgerber, Ulrich F. O. Luhmann, David P. Crabb, Adnan Tufail, Carel Hoyng, Moritz Berger, Matthias Schmid, Rufino Silva, Cecília V. Martinho, José Cunha-Vaz, Frank G. Holz, Robert P. Finger
Published in: BMC Medical Research Methodology, Issue 21/1, 2021, ISSN 1471-2288
Publisher: BioMed Central
DOI: 10.1186/s12874-021-01243-8

Use of composite endpoints in early and intermediate age-related macular degeneration clinical trials – state-of-the-art and future directions

Author(s): Jan Henrik Terheyden, Steffen Schmitz-Valckenberg, David P. Crabb, Hannah Dunbar, Ulrich F. O. Luhmann, Charlotte Behning, Matthias Schmid, Isabel Pires, José Cunha-Vaz, Adnan Tufail, Georges Weissgerber, Sergio Leal, Frank G. Holz, Robert P. Finger
Published in: Ophthalmologica, 2021, ISSN 0030-3755
Publisher: S. Karger AG
DOI: 10.1159/000513591

Test-Retest Variability and Discriminatory Power of Measurements From Microperimetry and Dark Adaptation Assessment in People With Intermediate Age-Related Macular Degeneration - A MACUSTAR Study Report

Author(s): Bethany E. Higgins; Giovanni Montesano; Hannah M. P. Dunbar; Alison M. Binns; Deanna J. Taylor; Charlotte Behning; Amina Abdirahman; Matthias C. Schmid; Jan H. Terheyden; Nadia Zakaria; Stephen Poor; Robert P. Finger; Sergio Leal; Frank G. Holz; Gary S. Rubin; Ulrich F. O. Luhmann; David P. Crabb; on behalf of the MACUSTAR Consortium
Published in: Translational Vision Science & Technology, Arvo Journal, 2023, ISSN 2164-2591
Publisher: ARVO
DOI: 10.1167/tvst.12.7.19

Repeatability and Discriminatory Power of Chart-Based Visual Function Tests in Individuals With Age-Related Macular Degeneration: A MACUSTAR Study Report

Author(s): Hannah M P Dunbar, Charlotte Behning, Amina Abdirahman, Bethany E Higgins , Alison M Binns, Jan H Terheyden, Nadia Zakaria, Stephen Poor, Robert P Finger, Sergio Leal, Frank G Holz, Matthias Schmid, David P Crabb, Gary S Rubin, Ulrich F O Luhmann, MACUSTAR Consortium
Published in: JAMA Ophthalmology, 2022, ISSN 2168-6165
Publisher: American Medical Association
DOI: 10.1001/jamaophthalmol.2022.2113

A New Method for Visualizing Drusen and Their Progression in Flood-Illumination Adaptive Optics Ophthalmoscopy

Author(s): Ethan A. Rossi; Nathaniel Norberg; Chiara Eandi; Celine Chaumette; Saloni Kapoor; Laura Le; Valerie C. Snyder; Joseph N. Martel; Josselin Gautier; Kiyoko Gocho; Kunal K. Dansingani; Jay Chhablani; Angelo Arleo; Sarah Mrejen; José-Alain Sahel; Kate Grieve; Michel Paques
Published in: Translational Vision Science & Technology, Issue 10/14, 2021, ISSN 2164-2591
Publisher: Association for Research in Vision and Ophthalmology
DOI: 10.1167/tvst.10.14.19

Optimising assessment of dark adaptation data using time to event analysis

Author(s): Bethany E. Higgins, Giovanni Montesano, Alison M. Binns, David P. Crabb
Published in: Scientific Reports, Issue 11/1, 2021, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-021-86193-3

Structure–Function Analysis in Macular Drusen With Mesopic and Scotopic Microperimetry

Author(s): Giovanni Montesano, Giovanni Ometto, Bethany E. Higgins, Costanza Iester, Konstantinos Balaskas, Adnan Tufail, Usha Chakravarthy, Ruth E. Hogg, David P. Crabb
Published in: Translational Vision Science & Technology, Issue 9/13, 2020, Page(s) 43, ISSN 2164-2591
Publisher: Association for Research in Vision and Ophthalmology
DOI: 10.1167/tvst.9.13.43

Comparability of automated drusen volume measurements in age-related macular degeneration: a MACUSTAR study report

Author(s): Davide Garzone, Jan Henrik Terheyden, Olivier Morelle, Maximilian W. M. Wintergerst, Marlene Saßmannshausen, Steffen Schmitz-Valckenberg, Maximilian Pfau, Sarah Thiele, Stephen Poor, Sergio Leal, Frank G. Holz, Robert P. Finger & MACUSTAR Consortium
Published in: Nature Scientific Reports, 2022, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-022-26223-w

Retest variability and patient reliability indices of quantitative fundus autofluorescence in age-related macular degeneration: a MACUSTAR study report

Author(s): Leon von der Emde, Merten Mallwitz, Marc Vaisband, Jan Hasenauer, Marlene Saßmannshausen, Jan Henrik Terheyden, MACUSTAR Consortium, Kenneth R. Sloan, Steffen Schmitz-Valckenberg, Robert P. Finger, Frank G. Holz & Thomas Ach
Published in: Nature Scientific Reports, 2023, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-023-43417-y

Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention—MACUSTAR

Author(s): Jan H. Terheyden, Frank G. Holz, Steffen Schmitz-Valckenberg, Anna Lüning, Matthias Schmid, Gary S. Rubin, Hannah Dunbar, Adnan Tufail, David P. Crabb, Alison Binns, Clara I. Sánchez, Carel Hoyng, Philippe Margaron, Nadia Zakaria, Mary Durbin, Ulrich Luhmann, Parisa Zamiri, José Cunha-Vaz, Cecília Martinho, Sergio Leal, Robert P. Finger
Published in: Trials, Issue 21/1, 2020, ISSN 1745-6215
Publisher: BioMed Central
DOI: 10.1186/s13063-020-04595-6

MACUSTAR: Development and Clinical Validation of Functional, Structural, and Patient-Reported Endpoints in Intermediate Age-Related Macular Degeneration

Author(s): 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
Published in: Ophthalmologica, 2018, Page(s) 1-12, ISSN 0030-3755
Publisher: S. Karger AG
DOI: 10.1159/000491402

EVICR. net. European Network of Clinical Research in Ophthalmology. Information Update - June 2017

Author(s): C. Martinho, D. Fernandes
Published in: Ophthalmic Research, Issue 58/2, 2017, Page(s) 107-113, ISSN 0030-3747
Publisher: S. Karger AG
DOI: 10.1159/000478073

European Network of Clinical Research in Ophthalmology Information Update – December 2018

Author(s): Cecília V. Martinho, Daniel Sanches Fernandes
Published in: Ophthalmic Research, Issue 61/4, 2019, Page(s) 183-187, ISSN 0030-3747
Publisher: S. Karger AG
DOI: 10.1159/000496497

MACUSTAR: Entwicklung und klinische Validierung von funktionellen, strukturellen und patientenberichteten Endpunkten bei intermediärer altersabhängiger Makuladegeneration

Author(s): 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
Published in: Der Ophthalmologe, 2019, ISSN 0941-293X
Publisher: Springer Verlag
DOI: 10.1007/s00347-019-0907-1

Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration - a MACUSTAR study report

Author(s): Jan Henrik Terheyden, Susanne G Pondorfer, Charlotte Behning, Moritz Berger, Jill Carlton, Donna Rowen, Christine Bouchet, Stephen Poor, Ulrich F O Luhmann, Sergio Leal, Frank G Holz, Thomas Butt, John E Brazier, Robert P Finger, MACUSTAR consortium
Published in: British Journal of Ophtalmology, 2022, ISSN 0007-1161
Publisher: BMJ Publishing Group
DOI: 10.1136/bjophthalmol-2021-320848

Intersession Repeatability of Structural Biomarkers in Early and Intermediate Age-Related Macular Degeneration: A MACUSTAR Study Report

Author(s): Marlene Saßmannshausen, Sarah Thiele, Charlotte Behning, Maximilian Pfau, Matthias Schmid, Sérgio Leal, Ulrich F O Luhmann, Robert P Finger, Frank G Holz, Steffen Schmitz-Valckenberg, MACUSTAR Consortium
Published in: Translational Vision Science & Technology, 2022, ISSN 2164-2591
Publisher: Association for Research in Vision and Ophthalmology
DOI: 10.1167/tvst.11.3.27

Clinical Perspectives and Trends: Microperimetry as a trial endpoint in retinal disease

Author(s): Yesa Yang, Hannah Dunbar
Published in: Ophthalmologica, 2021, ISSN 0030-3755
Publisher: S. Karger AG
DOI: 10.1159/000515148

Development and valuation of a preference-weighted measure in Age-Related Macular Degeneration from the Vision Impairment in Low Luminance (VILL) questionnaire - A MACUSTAR report

Author(s): Donna Rowen, Jill Carlton, Jan H Terheyden, Robert P Finger, Nyantara Wickramasekera, John Brazier; MACUSTAR Consortium
Published in: Value in Health, Issue 16:S1098-3015(24)00068-8, 2024, ISSN 1524-4733
Publisher: ScienceDirect
DOI: 10.1016/j.jval.2024.02.001

Discriminating intermediate AMD from normal aging changes using multiple visual function tests: A MACUSTAR study report

Author(s): Charlotte Behning, Jan H. Terheyden, Hannah Dunbar, Alison Binns, David P. Crabb, Frank G. Holz, Ulrich F. O. Luhmann, Matthias Schmid, Robert P. Finger
Published in: EURETINA 2023 Virtual Abstracts, 2023
Publisher: Medical Retina

Patient-reported vision impairment in low luminance and general health domains in intermediate age-related macular degeneration: A MACUSTAR study report

Author(s): Jan Henrik Terheyden, Charlotte Behning, Donna Rowen, David P. Crabb, Jill Carlton, Stephen Poor, Ulrich F. O. Luhmann, Sergio Leal, Matthias Schmid, Frank G. Holz, Robert P. Finger, Robert P. Finger, MACUSTAR Consortium
Published in: EURETINA 2023 Virtual Abstracts, 2023
Publisher: Euretina

Retinotopic sensitivity prediction in age-related macular degeneration based on optical coherence tomography data

Author(s): Philippe Valmaggia, Giovanni Montesano, Bethany E. Higgins, Hannah Dunbar, Coen de Vente, Clara I. Sánchez, Maximilian Pfau, Jan H. Terheyden, Sarah Thiele, Nadia Zakaria, Ulrich F.O. Luhmann, Ulrich F.O. Luhmann, Frank G. Holz, Steffen Schmitz-Valckenberg, David P. Crabb, Adnan Tufail, MACUSTAR Consortium
Published in: EURETINA 2023 Virtual Abstracts, 2023
Publisher: EURETINA

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

Deliverables

Publications

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