Evidence map›Paper›PMID 32066561›Full record

Observational studyThe British journal of ophthalmology2020

ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD).

Sandra Liakopoulos, Georg Spital, Christian K Brinkmann, Tina Schick, Focke Ziemssen, Jessica Voegeler, Mirja Koch, Bernd Kirchhof, Frank G Holz, Daniel Pauleikhoff and 1 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The British journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02194803 (Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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.

NCT02194803 completednot on this map

Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications

TypeobservationalSponsorNovartis PharmaceuticalsRan2011 to 2016Enrolled5,778ConditionsNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

11 authors.

Sandra LiakopoulosDepartment of Ophthalmology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany sandra.liakopoulos@uk-koeln.de.ORCID 0000-0003-3539-4372
Georg SpitalM3 Reading Center, Eye Center, St. Franziskus-Hospital Muenster, Muenster, Germany.
Christian K BrinkmannDepartment of Ophthalmology, Rheinische Friedrich-Wilhelms-Universitat Bonn, Bonn, Germany.
Tina SchickOphthalmology, University of Cologne, Cologne, Germany.
Focke ZiemssenDepartment for Ophthalmology, Eberhard Karl University Tuebingen, Tuebingen, Germany.
Jessica VoegelerNovartis Pharma GmbH, Nuremberg, Germany.
Mirja KochNovartis Pharma GmbH, Nuremberg, Germany.
Bernd KirchhofDepartment of Ophthalmology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Frank G HolzDepartment of Ophthalmology, Rheinische Friedrich-Wilhelms-Universitat Bonn, Bonn, Germany.
Daniel PauleikhoffDepartment of Ophthalmology, St. Franzikus-Hospital, Münster, Germany.
Steffen Schmitz-ValckenbergDepartment of Ophthalmology, Rheinische Friedrich-Wilhelms-Universitat Bonn, Bonn, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD).

methods2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated.

resultsCNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit.

conclusionAlthough broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required. TRIAL REGISTRATION NUMBER: NCT02194803.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsChoroidal NeovascularizationFemaleFluorescein AngiographyFollow-Up StudiesHumansIntravitreal InjectionsMaleProspective StudiesRanibizumabSubretinal FluidTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor AVEGFA protein, humanmaculaneovascularisationretina

Identifiers

PMID32066561
PMCPMC7587226

What OpenQuestion holds

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Registered trials

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.