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Acta Ophthalmol. 2018 Dec;96(8):e942-e949. doi: 10.1111/aos.13771. Epub 2018 Apr 25.

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

Collaborators (190)

Souied E, Lalloum F, Querques G, Ayello-Scheer S, Coriat C, Girens JF, Sahel JA, Creuzot-Garcher C, Bremond-Gignac D, Chiambaretta F, Farguette F, Delhay C, Baillif-Gostoli S, Maschi C, Fajnkuchen F, Milazzo S, Benzerroug M, Théron JP, Schmickler S, Zywien A, Bopp S, Höh H, Câmpean P, Schattmann K, Fromberg I, Fromberg C, Fromberg D, Spital G, Heimes B, Emmerich KH, Lang M, Krieb A, Xafis G, Stock L, Klotz N, Ungerechts R, Matuschek A, Radermacher M, Thelen U, Tetz M, Denisiuk M, Berens U, Schumacher A, Neuhann T, Lange O, Richard G, Wieland M, Filev F, Bittersohl D, Wiedemann P, Lorenz K, Wasielica-Poslednik J, Rosbach J, Dave H, Wirtz N, Weber B, Gelisken F, Wilhelm B, Peters T, König T, Kampik A, Abbasova S, Wolf A, Kurz S, Herold T, Arend N, Dabov S, Prause K, Fazekas C, Märtz J, Bayerl K, Heuer U, Bischoff G, Künne C, Lorenz B, Jäger M, Schiel H, Datseris I, Diamanti-Ramza A, Charonis A, Straga I, Babouli N, Brevetti C, Tranos P, Perganta G, Panayiotis T, Angeliki A, Dinioti T, Tsironi E, Kotoula M, Brazitikos P, Nanas D, Figueira J, Ribeiro L, Molodkina N, Abdulaeva E, Pashtaev N, Ovchinnikova V, Yurieva T, Vaycheslav B, Liya R, Ahlers J, Zmatlova I, Popovcova M, Bajacek J, Panisova J, Struharova K, Sturova L, Jamrichova Z, Krasnik V, Krajcova P, Hasa J, Piovarciova E, Gajdosova M, Vida R, Janco L, Leskova V, Demsky P, Alexik M, Falatova A, Lipkova B, Stubna M, Tomaskova D, Herle D, Martinez Alday N, Sanchez Aparicio JA, Martinez Anton M, Lopez Galvez MI, Manzanas Leal L, Juberias Sanchez R, Perez Belmonte L, Fernandez-Vega Sanz B, Villota Deleu E, Gloria DLTC, Canga S, De Santiago Rodiguez MA, Ramos Gonzalez D, Prieto Maratin JF, Franco Suarez-Barcena I, Casado Prieto A, Hernandez Galilea E, Gomez Ledesma I, de Juan Marco L, Mendivil Soto MP, Bearan I, Nuñez M, Lopez Garrido JL, Rodriguez Raton A, Cincunegui J, Vazquez Cruchaga E, Quiroga de la Hera P, Fernandez Rodriguez M, Rodriguez Cid MJ, Méndez Martínez S, Gonzalez Martinez A, Gomez-Ulla F, Garcia Garcés I, Martinez Perez L, Mansilla Cuñarro R, Abraldes Lopez-Veiga M, Rodriguez Nuñez M, Piñeiro Figuera MC, Rodriguez Ferro F, Menon G, North L, Chandran M, Retnamma R, Sivaprasad S, Taylor S, Scanlon P, Johnston R, Chong V, Mall S, Bailey C, Varma D, Talks J, Lotery A, Thulasidharan S, Eckstein M, Fahd Q, Koshy Z, Hanumanthu S, Kelly S, Evangelos S, Ghanchi F, Asaria R, Harris M, Derdeb T, Dipa G, Mahuma I.

Author information

1
Department of Ophthalmology, Medical Faculty, Comenius University, Bratislava, Slovakia.
2
Association for Innovation and Biomedical Research on Light and Image (AIBILI, Portugal), University of Coimbra, Coimbra, Portugal.
3
Department of Ophthalmology, Technical University of Munich, Munich, Germany.
4
St. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.
5
Fernández-Vega Ophthalmology Institute, Oviedo, Spain.
6
Attikon University General Hospital, 2nd University Ophthalmology Clinic, University of Athens, Athens, Greece.
7
Department of Ophthalmology, Croix-Rousse Teaching Hospital, University of Medicine Lyon 1, Lyon, France.
8
FSBI The Academician S.N. Fyodorov IRTC 'Eye Microsurgery' of the Minzdravsocrazvitiya - St. Petersburg, Saint Petersburg, Russia.
9
Bayer US, LLC, Whippany, NJ, USA.
10
Bayer AG, Wuppertal, Germany.
11
Bayer AG, Berlin, Germany.
12
Kantar Health GmbH, Munich, Germany.

Abstract

PURPOSE:

Antivascular 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.

METHODS:

POLARIS 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.

RESULTS:

Outcomes 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).

CONCLUSION:

POLARIS 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.

KEYWORDS:

anti-VEGF; diabetic macular oedema; ranibizumab

PMID:
29696809
PMCID:
PMC6585847
DOI:
10.1111/aos.13771
[Indexed for MEDLINE]
Free PMC Article

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