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

Author

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., 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., and Mahuma, I.

Subjects
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
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 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.

Published
2018

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

Author

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

Subjects
genetic structures, eye diseases
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.

Published
2018

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