UCL Discovery Stage
UCL home » Library Services » Electronic resources » UCL Discovery Stage

Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Terheyden, JH; Finger, RP; Schmitz-Valckenberg, S; Agostini, H; Dahlke, C; Kuehlewein, L; Lang, GE; ... Zamiri, P; + view all (2019) Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR. Der Ophthalmologe , 116 (12) pp. 1186-1193. 10.1007/s00347-019-0907-1. Green open access

[thumbnail of MACUSTAR_Ophthalmologe_2019.pdf]
Preview
Text
MACUSTAR_Ophthalmologe_2019.pdf - Accepted Version

Download (303kB) | Preview

Abstract

Background Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Type: Article
Title: Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR
Open access status: An open access version is available from UCL Discovery
DOI: 10.1007/s00347-019-0907-1
Publisher version: https://doi.org/10.1007/s00347-019-0907-1
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Science & Technology, Life Sciences & Biomedicine, Ophthalmology, Intermediate age-related macular degeneration, Disease progression, Clinical endpoint, Patient-reported outcome, Structure-function correlation, VISUAL-ACUITY LOSS, GEOGRAPHIC ATROPHY, DARK-ADAPTATION, MICROPERIMETRY, DRUSEN, DYSFUNCTION, IMPAIRMENT, PREVALENCE
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery-pp.ucl.ac.uk/id/eprint/10102423
Downloads since deposit
2,628Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item