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

Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde
Robert P Fingeron behalf of the MACUSTAR consortium

Abstract

Currently, no outcome measures are clinically validated and accepted as clinical endpoints by regulatory agencies for drug development in intermediate age-related macular degeneration (iAMD). The MACUSTAR Consortium, a public-private research group funded by the European Innovative Medicines Initiative intends to close this gap. Development of study protocol and statistical analysis plan including predictive modelling of multimodal endpoints based on a review of the literature and expert consensus. This observational study consists of a cross-sectional and a longitudinal part. Functional outcome measures assessed under low contrast and low luminance have the potential to detect progression of visual deficit within iAMD and to late AMD. Structural outcome measures will be multimodal and investigate topographical relationships with function. Current patient-reported outcome measures (PROMs) are not acceptable to regulators and may not capture the functional deficit specific to iAMD with needed precision, justifying development of novel PROMs for iAMD. The total sample size will be n = 750, consisting mainly of subjects with iAMD (n = 600). As clinical endpoints currently accepted by regulators cannot detect functional loss or pat...Continue Reading

References

Apr 5, 2000·Vision Research·G R JacksonG McGwin
May 17, 2002·Ophthalmic & Physiological Optics : the Journal of the British College of Ophthalmic Opticians (Optometrists)·Sharon A HaymesAnthony D Heyes
Dec 4, 2003·Journal of Alzheimer's Disease : JAD·Danielle J HarveyDan M Mungas
Apr 4, 2006·Progress in Retinal and Eye Research·R E Hogg, U Chakravarthy
Apr 12, 2006·Archives of Ophthalmology·Cristina A AugoodAstrid E Fletcher
Sep 8, 2007·Ophthalmology·Cynthia OwsleyMark Clark
Aug 2, 2008·Eye·B WeingesselU Schmidt-Erfurth
Aug 2, 2008·Ophthalmology·Gui-Shuang YingUNKNOWN Complications of Age-related Macular Degeneration Prevention Trial Research Group
May 18, 2010·Ophthalmology·Edoardo MidenaUNKNOWN Microperimetry Study Group
May 28, 2010·Investigative Ophthalmology & Visual Science·Haogang ZhuDavid F Garway-Heath
Aug 31, 2010·Ophthalmology·Gui-Shuang YingUNKNOWN Complications of Age-related Macular Degeneration Prevention Trial Research Group
Dec 17, 2010·Ophthalmic & Physiological Optics : the Journal of the British College of Ophthalmic Opticians (Optometrists)·Nilpa ShahRoger S Anderson
Mar 8, 2011·The British Journal of Ophthalmology·Robert P FingerHendrik P N Scholl
Jan 24, 2012·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Jonathan ToshLouise Longworth
May 9, 2012·Lancet·Laurence S LimTien Y Wong
Jan 22, 2013·Ophthalmology·Frederick L FerrisUNKNOWN Beckman Initiative for Macular Research Classification Committee
Mar 20, 2013·Vision Research·Gary S Rubin
Apr 11, 2013·Investigative Ophthalmology & Visual Science·Mark J J P van GrinsvenClara I Sánchez
Jan 18, 2014·Ophthalmology·Frank G HolzMenno van Lookeren Campagne
Apr 8, 2014·Optometry and Vision Science : Official Publication of the American Academy of Optometry·Gregory R JacksonMitchell G Brigell
Jul 30, 2014·Biomedical Optics Express·Haogang ZhuDavid P Crabb
Dec 24, 2014·BMC Medical Research Methodology·Tjeerd van der PloegEwout W Steyerberg
Jan 13, 2015·Investigative Ophthalmology & Visual Science·Mark J J P van GrinsvenClara I Sánchez
Mar 27, 2015·JAMA Ophthalmology·Julia S SteinbergSteffen Schmitz-Valckenberg
Aug 8, 2015·The British Journal of Ophthalmology·Zhichao WuRobert P Finger
Feb 6, 2016·The British Journal of Ophthalmology·Nilpa ShahRoger S Anderson
Mar 5, 2016·American Journal of Ophthalmology·Monica B SevillaCynthia A Toth
Apr 25, 2017·Investigative Ophthalmology & Visual Science·Freerk G VenhuizenClara I Sánchez
Jul 18, 2017·Ophthalmology·Johanna M ColijnUNKNOWN European Eye Epidemiology (E3) consortium
Jul 18, 2017·Translational Vision Science & Technology·Julia S SteinbergSteffen Schmitz-Valckenberg
Jul 22, 2017·Translational Vision Science & Technology·Maximilian W M WintergerstRobert P Finger
Dec 1, 2017·Biomedical Optics Express·Bart LiefersClara I Sánchez

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Citations

Apr 2, 2020·Investigative Ophthalmology & Visual Science·Susanne G PondorferRobert P Finger
May 16, 2019·Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft·Jan H TerheydenUNKNOWN MACUSTAR-Konsortium
Oct 28, 2019·Scientific Reports·Susanne G PondorferRobert P Finger
Oct 8, 2019·Translational Vision Science & Technology·Myra B McGuinnessUNKNOWN LEAD Study Group
Jan 7, 2021·Ophthalmic & Physiological Optics : the Journal of the British College of Ophthalmic Opticians (Optometrists)·Laura J WoodRobert E MacLaren
Jan 29, 2021·Translational Vision Science & Technology·Susanne G PondorferRobert P Finger
Jan 15, 2021·Translational Vision Science & Technology·Giovanni MontesanoDavid P Crabb
Oct 7, 2020·Progress in Retinal and Eye Research·Maximilian PfauSteffen Schmitz-Valckenberg
Mar 19, 2021·BMC Medical Research Methodology·Jan Henrik TerheydenUNKNOWN MACUSTAR consortium
Mar 20, 2021·Graefe's Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Für Klinische Und Experimentelle Ophthalmologie·Cláudia FarinhaRufino Silva
May 8, 2021·Nature Reviews. Disease Primers·Monika FleckensteinEmily Y Chew
Aug 6, 2021·American Journal of Ophthalmology·Kristin RamingKristina Hess
Aug 19, 2021·BMC Medical Research Methodology·Charlotte BehningMatthias Schmid
Jan 29, 2019·Ophthalmic Research·Cecília V Martinho, Daniel Sanches Fernandes
Nov 17, 2020·Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde·Luísa S M MendonçaNadia K Waheed
Dec 8, 2020·Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde·Jan Henrik TerheydenUNKNOWN on behalf of the MACUSTAR Consortium
Feb 11, 2021·Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde·Yesa Yang, Hannah Dunbar
Feb 25, 2021·Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift für Augenheilkunde·Chui Ming Gemmy CheungSobha Sivaprasad
Nov 30, 2021·Ophthalmic & Physiological Optics : the Journal of the British College of Ophthalmic Opticians (Optometrists)·Matt TrinhLisa Nivison-Smith

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