Evidence map›Paper›PMID 29696809›Full record

ArticleActa ophthalmologica2018

A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS).

Jana Stefanickova, Jose Cunha-Vaz, Michael Ulbig, Ian Pearce, Alvaro Fernández-Vega Sanz, Panagiotis Theodossiadis, Laurent Kodjikian, Alexander Izmailov, Dominic Muston, Zdravko Vassilev and 7 more

Open access · bronzeAbstract readClinical StudyMulticenter Study
In one paragraph

Article in Acta ophthalmologica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
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

13 citing papers in PubMed, 33 citations in OpenAlex.

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  6. [The Hamburg register for intravitreal injection therapies (QIVOM)].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2022
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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

17 authors at 11 institutions in 9 countries.

Jana StefanickovaDepartment of Ophthalmology, Medical Faculty, Comenius University, Bratislava, Slovakia.
Jose Cunha-VazAssociation for Innovation and Biomedical Research on Light and Image (AIBILI, Portugal), University of Coimbra, Coimbra, Portugal.
Michael UlbigDepartment of Ophthalmology, Technical University of Munich, Munich, Germany.
Ian PearceSt. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.
Alvaro Fernández-Vega SanzFernández-Vega Ophthalmology Institute, Oviedo, Spain.
Panagiotis TheodossiadisAttikon University General Hospital, 2nd University Ophthalmology Clinic, University of Athens, Athens, Greece.
Laurent KodjikianDepartment of Ophthalmology, Croix-Rousse Teaching Hospital, University of Medicine Lyon 1, Lyon, France.
Alexander IzmailovFSBI The Academician S.N. Fyodorov IRTC 'Eye Microsurgery' of the Minzdravsocrazvitiya - St. Petersburg, Saint Petersburg, Russia.
Dominic MustonBayer US, LLC, Whippany, NJ, USA.
Zdravko VassilevBayer US, LLC, Whippany, NJ, USA.
Benedicte LamotteBayer US, LLC, Whippany, NJ, USA.
Claudia TückmantelBayer AG, Wuppertal, Germany.
Sabine FriedlBayer AG, Berlin, Germany.
Andreas AltemarkBayer AG, Berlin, Germany.
Hans-Jörg SchwarzKantar Health GmbH, Munich, Germany.
Todd KatzBayer US, LLC, Whippany, NJ, USA.
POLARIS study investigators
Bayer (United States) · USBayer (Germany) · DEAssociation for Innovation and Biomedical Research on Light and Image · PTComenius University Bratislava · SKFernández-Vega Ophthalmological Institute · ESIntersectoral Research and Technology Complex Eye Microsurgery · RUKantar (Germany) · DETechnical University of Munich · DEUniversité Claude Bernard Lyon 1 · FRUniversity General Hospital Attikon · GRUniversity of Liverpool · GB

Funding

Bayer AG
6 · The paper itself

Abstract

purposeAntivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings.

methodsPOLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency.

resultsOutcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3-5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was -115.2 μm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters).

conclusionPOLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.

Indexed as

Visual AcuityAngiogenesis InhibitorsDiabetic RetinopathyDose-Response Relationship, DrugDrug Administration ScheduleEuropeFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsMacula LuteaMacular EdemaMaleMiddle AgedAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor Aanti-VEGFdiabetic macular oedemaranibizumab

Identifiers

PMID29696809
PMCPMC6585847
OpenAlexW2799394289

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.