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

Επιστημονική δημοσίευση - Άρθρο Περιοδικού uoadl:3106816 55 Αναγνώσεις

Μονάδα:
Ερευνητικό υλικό ΕΚΠΑ
Τίτλος:
A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Έτος δημοσίευσης:
2018
Συγγραφείς:
Stefanickova, J.
Cunha-Vaz, J.
Ulbig, M.
Pearce, I.
Fernández-Vega Sanz, A.
Theodossiadis, P.
Kodjikian, L.
Izmailov, A.
Muston, D.
Vassilev, Z.
Lamotte, B.
Tückmantel, C.
Friedl, S.
Altemark, A.
Schwarz, H.-J.
Katz, T.
Souied, E.
Lalloum, F.
Querques, G.
Ayello-Scheer, S.
Coriat, C.
Girens, J.F.
Sahel, J.-A.
Creuzot-Garcher, C.
Bremond-Gignac, D.
Chiambaretta, F.
Farguette, F.
Delhay, C.
Baillif-Gostoli, S.
Maschi, C.
Fajnkuchen, F.
Milazzo, S.
Benzerroug, M.
Théron, J.P.
Schmickler, S.
Zywien, A.
Bopp, S.
Höh, H.
Câmpean, P.
Schattmann, K.
Fromberg, I.
Fromberg, C.
Fromberg, D.
Spital, G.
Heimes, B.
Emmerich, K.-H.
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, J.A.
Martinez Anton, M.
Lopez Galvez, M.I.
Manzanas Leal, L.
Juberias Sanchez, R.
Perez Belmonte, L.
Fernandez-Vega Sanz, B.
Villota Deleu, E.
Gloria, D.L.T.C.
Canga, S.
De Santiago Rodiguez, M.A.
Ramos Gonzalez, D.
Prieto Maratin, J.F.
Franco Suarez-Barcena, I.
Casado Prieto, A.
Hernandez Galilea, E.
Gomez Ledesma, I.
de Juan Marco, L.
Mendivil Soto, M.P.
Bearan, I.
Nuñez, M.
Lopez Garrido, J.L.
Rodriguez Raton, A.
Cincunegui, J.
Vazquez Cruchaga, E.
Quiroga de la Hera, P.
Fernandez Rodriguez, M.
Rodriguez Cid, M.J.
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, M.C.
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.
the POLARIS study investigators
Περιοδικό:
Acta Ophthalmologica
Εκδότης:
Wiley-Blackwell Publishing Ltd
Τόμος:
96
Αριθμός / τεύχος:
8
Σελίδες:
e942-e949
Λέξεις-κλειδιά:
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
Επίσημο URL (Εκδότης):
DOI:
10.1111/aos.13771
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