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.
A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS) / Stefanickova, J.; Cunha-Vaz, J.; Ulbig, M.; Pearce, I.; Fernandez-Vega Sanz, A.; Theodossiadis, P.; Kodjikian, L.; Izmailov, A.; Muston, D.; Vassilev, Z.; Lamotte, B.; Tuckmantel, 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.; Theron, J. P.; Schmickler, S.; Zywien, A.; Bopp, S.; Hoh, H.; Campean, 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.; Konig, T.; Kampik, A.; Abbasova, S.; Wolf, A.; Kurz, S.; Herold, T.; Arend, N.; Dabov, S.; Prause, K.; Fazekas, C.; Martz, J.; Bayerl, K.; Heuer, U.; Bischoff, G.; Kunne, C.; Lorenz, B.; Jager, 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.; Nunez, 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.; Mendez Martinez, S.; Gonzalez Martinez, A.; Gomez-Ulla, F.; Garcia Garces, I.; Martinez Perez, L.; Mansilla Cunarro, R.; Abraldes Lopez-Veiga, M.; Rodriguez Nunez, M.; Pineiro 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.. - In: ACTA OPHTHALMOLOGICA. - ISSN 1755-375X. - 96:8(2018), pp. e942-e949. [10.1111/aos.13771]
A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)
Querques G.;
2018-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
