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22. 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

24. 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

26. Efficacité en vie réelle du traitement par injection intravitréenne de ranibizumab pour une baisse de l’acuité visuelle due à un œdème maculaire secondaire à une occlusion veineuse rétinienne : résultats finaux à 24 mois de suivi des cohortes BOREAL

Author

Blin, P., primary, Delcourt, C., additional, Glacet-Bernard, A., additional, Creuzot-Garcher, C., additional, Fajnkuchen, F., additional, Girmens, J.-F., additional, Guillausseau, P.-J., additional, Kodjikian, L., additional, Massin, P., additional, Lassalle, R., additional, Bernard, M.-A., additional, Chartier, A., additional, Diez, P., additional, Hamoud, F., additional, Maïzi, H., additional, Mahé, M., additional, Droz-Perroteau, C., additional, Grolleau, A., additional, Grelaud, A., additional, and Moore, N., additional

Published
2018
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27. Efficacité en vie réelle du traitement par injection intravitréenne de ranibizumab pour une baisse de l’acuité visuelle due à un œdème maculaire secondaire à une occlusion veineuse rétinienne : les cohortes BOREAL

Author

Blin, P., primary, Delcourt, C., additional, Glacet-Bernard, A., additional, Fajnkuchen, F., additional, Girmens, J.-F., additional, Lassalle, R., additional, Chartier, A., additional, Bernard, M.-A., additional, Diez, P., additional, Douina, N., additional, Le Monies de Sagazan, A., additional, Finzi, L., additional, Droz-Perroteau, C., additional, Grolleau, A., additional, Grelaud, A., additional, and Moore, N., additional

Published
2017
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29. Physician information sheet: Treatment of diabetic macular edema

Author

Massin, P., Baillif, S., Creuzot Garcher, Catherine, Fajnkuchen, F., Kodjikian, Laurent, Université Paris Diderot - Paris 7 ( UPD7 ), Université Nice Sophia Antipolis ( UNS ), Université Côte d'Azur ( UCA ), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Centre des Sciences du Goût et de l'Alimentation [Dijon] ( CSGA ), Institut National de la Recherche Agronomique ( INRA ) -Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre National de la Recherche Scientifique ( CNRS ), Centre d’imagerie et de laser, Hôpital Avicenne, Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon ( HCL ), Université Paris Diderot - Paris 7 (UPD7), Université Nice Sophia Antipolis (... - 2019) (UNS), Université Côte d'Azur (UCA), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre des Sciences du Goût et de l'Alimentation [Dijon] (CSGA), Institut National de la Recherche Agronomique (INRA)-Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA), Hôpital Avicenne [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
dexamethasone intravitreal implant, deferred, trial, triamcinolone, laser, 3-year, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, [ SDV.MHEP.OS ] Life Sciences [q-bio]/Human health and pathology/Sensory Organs, retinopathy, follow-up, ranibizumab plus prompt, [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs, risk-factors, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, photocoagulation
Abstract

absent

Published
2015

33. Sustained intraocular pressure elevation in eyes treated with intravitreal injections of anti-vascular endothelial growth factor for diabetic macular edema in a real-life setting.

Author

Kim, S., Fajnkuchen, F., Sarda, V., Qu-Knafo, L., Bodaghi, B., and Giocanti-Aurégan, A.

Subjects
*INTRAOCULAR pressure, *ENDOTHELIAL growth factors, *EDEMA, *GLAUCOMA, *VASCULAR endothelial growth factors
Abstract

Purpose: The aim of this study was to investigate the sustained intraocular pressure (IOP) elevation after repeated anti-VEGF intravitreal injections (IVI) in patients with diabetic macular edema (DME). Methods: A retrospective study included 140 eyes without prior glaucoma, treated with at least three anti-VEGF injections for DME between 2012 and 2016. IOP elevation was defined by an increase above baseline IOP by ≥6 mmHg. Baseline IOP was defined as the mean of IOP values before treatment initiation. Three groups were differentiated: group 1 without IOP elevation, groups 2 and 3 with IOP elevation and IOP <21 mmHg (group 2) and ≥21 mmHg (group 3). Rate and several risk factors of IOP elevation were assessed and compared between the three groups. Results: IOP elevation occurred in ten eyes (7.1%). IOP was <21 mmHg in six eyes and ≥21 mmHg in four eyes. Statistically significant associations were found between IOP elevation and the number of injections, and HbA1c level. Two patients required local hypotonic treatment. Conclusions: In a real-life setting, we confirmed in eyes with center-involved DME without prior glaucoma or IOP elevation that repeated anti-VEGF IVI may increase the risk of sustained IOP elevation in about 7% of eyes. [ABSTRACT FROM AUTHOR]

Published
2017
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