Evidence map›Paper›PMID 30153664›Full record

ReviewOphthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde2019

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

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 and 8 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  13. Initiation of a global consortium to study the progression of age-related macular degeneration: RIMR AMD consortium report # 1.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Robert P FingerDepartment of Ophthalmology, University of Bonn, Bonn, Germanyrobert.finger@ukbonn.de.
Steffen Schmitz-ValckenbergDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
Matthias SchmidInstitute for Medical Biometry, Epidemiology and Informatics, University Hospital Bonn, Bonn, Germany.
Gary S RubinUCL Institute of Ophthalmology, University College London, London, United Kingdom.
Hannah DunbarUCL Institute of Ophthalmology, University College London, London, United Kingdom.
Adnan TufailMoorfields Eye Hospital, London, United Kingdom.
David P CrabbDivision of Optometry and Visual Science, School of Health Sciences, City, University of London, London, United Kingdom.
Alison BinnsDivision of Optometry and Visual Science, School of Health Sciences, City, University of London, London, United Kingdom.
Clara I SánchezDiagnostic Image Analysis Group, Radboud University Medical Center, Nijmegen, The Netherlands.
Philippe MargaronNovartis Pharma AG, Basel, Switzerland.
Guillaume NormandNovartis Pharma AG, Basel, Switzerland.
Mary K DurbinCarl Zeiss Meditec AG, Dublin, California, USA.
Ulrich F O LuhmannRoche Pharmaceutical Research and Early Development, Translational Medicine Ophthalmology, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Parisa ZamiriNovartis Pharma AG, Basel, Switzerland.
José Cunha-VazAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Friedrich AsmusDevelopment Pharmaceuticals, Therapeutic Areas PAO, Bayer AG, Berlin, Germany.
Frank G HolzDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
on behalf of the MACUSTAR consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCurrently, 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. PROCEDURES: Development of study protocol and statistical analysis plan including predictive modelling of multimodal endpoints based on a review of the literature and expert consensus.

resultsThis 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).

conclusionsAs clinical endpoints currently accepted by regulators cannot detect functional loss or patient-relevant impact in iAMD, we will clinically validate novel candidate endpoints for iAMD.

Indexed as

Disease ManagementPatient Reported Outcome MeasuresVisual AcuityFluorescein AngiographyFundus OculiHumansMacular DegenerationRetinaTomography, Optical CoherenceClinical endpointDisease progressionIntermediate age-related macular degenerationPatient-reported outcomesStructure-function correlation

Identifiers

PMID30153664
PMCPMC6482983

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.