A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)
| Autor: | 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. |
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| Přispěvatelé: | 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. |
| Rok vydání: | 2018 |
| Předmět: |
Male
Vascular Endothelial Growth Factor A Time Factors Visual acuity genetic structures Visual Acuity Angiogenesis Inhibitors anti‐VEGF 0302 clinical medicine Primary outcome Retrospective Studie Medicine Macula Lutea 030212 general & internal medicine Fluorescein Angiography Anti vegf General Medicine Middle Aged ddc Europe anti-VEGF diabetic macular oedema Intravitreal Injections Original Article Female medicine.symptom Tomography Optical Coherence medicine.drug Angiogenesis Inhibitor Human medicine.medical_specialty Time Factor Fundus Oculi Drug Administration Schedule Macular Edema Follow-Up Studie 03 medical and health sciences Ophthalmology Ranibizumab Humans In patient Retrospective Studies Monitoring Physiologic Diabetic Retinopathy Dose-Response Relationship Drug business.industry Intravitreal Injection Original Articles eye diseases Confidence interval Diabetic macular oedema 030221 ophthalmology & optometry business Resource utilization Follow-Up Studies |
| Zdroj: | Acta Ophthalmologica |
| Popis: | 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 12months; 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 12months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was −115.2μm 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. |
| Databáze: | OpenAIRE |
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