@article{3106816,
    title = "A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)",
    author = "Stefanickova, J. and Cunha-Vaz, J. and Ulbig, M. and Pearce, I. and Fernández-Vega Sanz, A. and Theodossiadis, P. and Kodjikian, L. and Izmailov, A. and Muston, D. and Vassilev, Z. and Lamotte, B. and Tückmantel, C. and Friedl, S. and Altemark, A. and Schwarz, H.-J. and Katz, T. and Souied, E. and Lalloum, F. and Querques, G. and Ayello-Scheer, S. and Coriat, C. and Girens, J.F. and Sahel, J.-A. and Creuzot-Garcher, C. and Bremond-Gignac, D. and Chiambaretta, F. and Farguette, F. and Delhay, C. and Baillif-Gostoli, S. and Maschi, C. and Fajnkuchen, F. and Milazzo, S. and Benzerroug, M. and Théron, J.P. and Schmickler, S. and Zywien, A. and Bopp, S. and Höh, H. and Câmpean, P. and Schattmann, K. and Fromberg, I. and Fromberg, C. and Fromberg, D. and Spital, G. and Heimes, B. and Emmerich, K.-H. and Lang, M. and Krieb, A. and Xafis, G. and Stock, L. and Klotz, N. and Ungerechts, R. and Matuschek, A. and Radermacher, M. and Thelen, U. and Tetz, M. and Denisiuk, M. and Berens, U. and Schumacher, A. and Neuhann, T. and Lange, O. and Richard, G. and Wieland, M. and Filev, F. and Bittersohl, D. and Wiedemann, P. and Lorenz, K. and Wasielica-Poslednik, J. and Rosbach, J. and Dave, H. and Wirtz, N. and Weber, B. and Gelisken, F. and Wilhelm, B. and Peters, T. and König, T. and Kampik, A. and Abbasova, S. and Wolf, A. and Kurz, S. and Herold, T. and Arend, N. and Dabov, S. and Prause, K. and Fazekas, C. and Märtz, J. and Bayerl, K. and Heuer, U. and Bischoff, G. and Künne, C. and Lorenz, B. and Jäger, M. and Schiel, H. and Datseris, I. and Diamanti-Ramza, A. and Charonis, A. and Straga, I. and Babouli, N. and Brevetti, C. and Tranos, P. and Perganta, G. and Panayiotis, T. and Angeliki, A. and Dinioti, T. and Tsironi, E. and Kotoula, M. and Brazitikos, P. and Nanas, D. and Figueira, J. and Ribeiro, L. and Molodkina, N. and Abdulaeva, E. and Pashtaev, N. and Ovchinnikova, V. and Yurieva, T. and Vaycheslav, B. and Liya, R. and Ahlers, J. and Zmatlova, I. and Popovcova, M. and Bajacek, J. and Panisova, J. and Struharova, K. and Sturova, L. and Jamrichova, Z. and Krasnik, V. and Krajcova, P. and Hasa, J. and Piovarciova, E. and Gajdosova, M. and Vida, R. and Janco, L. and Leskova, V. and Demsky, P. and Alexik, M. and Falatova, A. and Lipkova, B. and Stubna, M. and Tomaskova, D. and Herle, D. and Martinez Alday, N. and Sanchez Aparicio, J.A. and Martinez Anton, M. and Lopez Galvez, M.I. and Manzanas Leal, L. and Juberias Sanchez, R. and Perez Belmonte, L. and Fernandez-Vega Sanz, B. and Villota Deleu, E. and Gloria, D.L.T.C. and Canga, S. and De Santiago Rodiguez, M.A. and Ramos Gonzalez, D. and Prieto Maratin, J.F. and Franco Suarez-Barcena, I. and Casado Prieto, A. and Hernandez Galilea, E. and Gomez Ledesma, I. and de Juan Marco, L. and Mendivil Soto, M.P. and Bearan, I. and Nuñez, M. and Lopez Garrido, J.L. and Rodriguez Raton, A. and Cincunegui, J. and Vazquez Cruchaga, E. and Quiroga de la Hera, P. and Fernandez Rodriguez, M. and Rodriguez Cid, M.J. and Méndez Martínez, S. and Gonzalez Martinez, A. and Gomez-Ulla, F. and Garcia Garcés, I. and Martinez Perez, L. and Mansilla Cuñarro, R. and Abraldes Lopez-Veiga, M. and Rodriguez Nuñez, M. and Piñeiro Figuera, M.C. and Rodriguez Ferro, F. and Menon, G. and North, L. and Chandran, M. and Retnamma, R. and Sivaprasad, S. and Taylor, S. and Scanlon, P. and Johnston, R. and Chong, V. and Mall, S. and Bailey, C. and Varma, D. and Talks, J. and Lotery, A. and Thulasidharan, S. and Eckstein, M. and Fahd, Q. and Koshy, Z. and Hanumanthu, S. and Kelly, S. and Evangelos, S. and Ghanchi, F. and Asaria, R. and Harris, M. and Derdeb, T. and Dipa, G. and Mahuma, I. and the POLARIS study investigators",
    journal = "Acta Ophthalmologica",
    year = "2018",
    volume = "96",
    number = "8",
    pages = "e942-e949",
    publisher = "Wiley-Blackwell Publishing Ltd",
    issn = "1755-375X, 1755-3768",
    doi = "10.1111/aos.13771",
    keywords = "ranibizumab;  angiogenesis inhibitor;  ranibizumab;  vasculotropin A, age;  aged;  Article;  central retinal thickness;  clinical outcome;  diabetic macular edema;  drug efficacy;  drug use;  female;  health care utilization;  human;  intervention study;  major clinical study;  male;  multicenter study;  outcome assessment;  patient monitoring;  priority journal;  scoring system;  sex;  visual acuity;  visual acuity score;  antagonists and inhibitors;  clinical trial;  complication;  diabetic retinopathy;  diagnostic imaging;  dose response;  drug administration;  Europe;  eye fundus;  fluorescence angiography;  follow up;  intravitreal drug administration;  macular edema;  middle aged;  optical coherence tomography;  pathophysiology;  physiologic monitoring;  procedures;  retina macula lutea;  retrospective study;  time factor;  visual acuity, Angiogenesis Inhibitors;  Diabetic Retinopathy;  Dose-Response Relationship, Drug;  Drug Administration Schedule;  Europe;  Female;  Fluorescein Angiography;  Follow-Up Studies;  Fundus Oculi;  Humans;  Intravitreal Injections;  Macula Lutea;  Macular Edema;  Male;  Middle Aged;  Monitoring, Physiologic;  Ranibizumab;  Retrospective Studies;  Time Factors;  Tomography, Optical Coherence;  Vascular Endothelial Growth Factor A;  Visual Acuity",
    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. © 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation."
}