ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema

Laurent Kodjikian,1 Amélie Lecleire-Collet,2 Corinne Dot,3 Marie-Laure Le Lez,4 Stéphanie Baillif,5 Ali Erginay,6 Eric Souied,7 Eric Fourmaux,8 Philippe Gain,9 Anne Ponthieux10 1Department of Ophthalmology, Croix-Rousse University Hospital, Lyon, France; 2Mathilde Clinic, Rouen...

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Autores principales:	Kodjikian L, Lecleire-Collet A, Dot C, Le Lez ML, Baillif S, Erginay A, Souied E, Fourmaux E, Gain P, Ponthieux A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	real-world study retinal thickness visual acuity switch induction Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/50aa141a92864c05904cba97ca928361
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spelling	oai:doaj.org-article:50aa141a92864c05904cba97ca9283612021-12-02T14:54:26ZETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema1177-5483https://doaj.org/article/50aa141a92864c05904cba97ca9283612021-06-01T00:00:00Zhttps://www.dovepress.com/etoile-real-world-evidence-of-24-months-of-ranibizumab-05-mg-in-patien-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Laurent Kodjikian,1 Amélie Lecleire-Collet,2 Corinne Dot,3 Marie-Laure Le Lez,4 Stéphanie Baillif,5 Ali Erginay,6 Eric Souied,7 Eric Fourmaux,8 Philippe Gain,9 Anne Ponthieux10 1Department of Ophthalmology, Croix-Rousse University Hospital, Lyon, France; 2Mathilde Clinic, Rouen, France; 3Department of Ophthalmology, Desgenettes Military Hospital, Lyon, France and French Military Health Service Academy, Val-de-Grâce, Paris, France; 4Ophthalmology Department, Centre Hospitalier Regional Universitaire de Tours, Tours, France; 5Department of Ophthalmology, Centre Hospitalier Universitaire de Nice, Hôpital Pasteur-2, Nice, France; 6Department of Ophthalmology, Lariboisière Hospital, AP HP, University Paris-Diderot Paris-7, Paris, France; 7Department of Ophthalmology, Hospital Intercommunal de Creteil, University Paris Est Creteil, Creteil, France; 8Centre Gallien, Bordeaux, France; 9Ophthalmology Department, University Hospital, Saint-Etienne, France, Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint‐Etienne, France; 10Novartis Pharma SAS, Rueil-Malmaison, FranceCorrespondence: Laurent KodjikianDepartment of Ophthalmology, Croix-Rousse University Hospital, 103 Grande Rue de la Croix-Rousse, Lyon, 69004, FranceTel +33 4 26 10 94 29Fax + 33 4 72 07 26 45Email Kodjikian.laurent@wanadoo.frPurpose: To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME).Patients and Methods: Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and followed up according to investigators’ usual procedures. Outcomes included change from baseline to month 24 in best-corrected VA (BCVA; primary outcome), central retinal thickness (CRT), treatment exposure and safety.Results: Overall, 62.9% of patients completed the study per protocol, 68.6% completed the induction phase (first three injections one month apart). On average, patients had 12.5 ophthalmologist visits and 5.74 injections in year 1, decreasing to 4.6 visits and 1.94 injections in year 2. Mean baseline BCVA was 58.4 letters, mean gain at M24 was +6.08 letters (95% CI: 2.95, 9.21). Gains were higher for patients who completed induction, and for patients who did not switch treatment. Mean CRT improved by 149.17 μm at M24. There were no new safety signals. BCVA variation of ≥ 6 letters by M3 was predictive of BCVA gains at M24 (p=0.007), as was hypertension medication at baseline (p=0.022).Conclusion: Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.Keywords: real-world study, retinal thickness, visual acuity, switch, inductionKodjikian LLecleire-Collet ADot CLe Lez MLBaillif SErginay ASouied EFourmaux EGain PPonthieux ADove Medical Pressarticlereal-world studyretinal thicknessvisual acuityswitchinductionOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 2307-2315 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	real-world study retinal thickness visual acuity switch induction Ophthalmology RE1-994
spellingShingle	real-world study retinal thickness visual acuity switch induction Ophthalmology RE1-994 Kodjikian L Lecleire-Collet A Dot C Le Lez ML Baillif S Erginay A Souied E Fourmaux E Gain P Ponthieux A ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
description	Laurent Kodjikian,1 Amélie Lecleire-Collet,2 Corinne Dot,3 Marie-Laure Le Lez,4 Stéphanie Baillif,5 Ali Erginay,6 Eric Souied,7 Eric Fourmaux,8 Philippe Gain,9 Anne Ponthieux10 1Department of Ophthalmology, Croix-Rousse University Hospital, Lyon, France; 2Mathilde Clinic, Rouen, France; 3Department of Ophthalmology, Desgenettes Military Hospital, Lyon, France and French Military Health Service Academy, Val-de-Grâce, Paris, France; 4Ophthalmology Department, Centre Hospitalier Regional Universitaire de Tours, Tours, France; 5Department of Ophthalmology, Centre Hospitalier Universitaire de Nice, Hôpital Pasteur-2, Nice, France; 6Department of Ophthalmology, Lariboisière Hospital, AP HP, University Paris-Diderot Paris-7, Paris, France; 7Department of Ophthalmology, Hospital Intercommunal de Creteil, University Paris Est Creteil, Creteil, France; 8Centre Gallien, Bordeaux, France; 9Ophthalmology Department, University Hospital, Saint-Etienne, France, Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint‐Etienne, France; 10Novartis Pharma SAS, Rueil-Malmaison, FranceCorrespondence: Laurent KodjikianDepartment of Ophthalmology, Croix-Rousse University Hospital, 103 Grande Rue de la Croix-Rousse, Lyon, 69004, FranceTel +33 4 26 10 94 29Fax + 33 4 72 07 26 45Email Kodjikian.laurent@wanadoo.frPurpose: To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME).Patients and Methods: Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and followed up according to investigators’ usual procedures. Outcomes included change from baseline to month 24 in best-corrected VA (BCVA; primary outcome), central retinal thickness (CRT), treatment exposure and safety.Results: Overall, 62.9% of patients completed the study per protocol, 68.6% completed the induction phase (first three injections one month apart). On average, patients had 12.5 ophthalmologist visits and 5.74 injections in year 1, decreasing to 4.6 visits and 1.94 injections in year 2. Mean baseline BCVA was 58.4 letters, mean gain at M24 was +6.08 letters (95% CI: 2.95, 9.21). Gains were higher for patients who completed induction, and for patients who did not switch treatment. Mean CRT improved by 149.17 μm at M24. There were no new safety signals. BCVA variation of ≥ 6 letters by M3 was predictive of BCVA gains at M24 (p=0.007), as was hypertension medication at baseline (p=0.022).Conclusion: Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.Keywords: real-world study, retinal thickness, visual acuity, switch, induction
format	article
author	Kodjikian L Lecleire-Collet A Dot C Le Lez ML Baillif S Erginay A Souied E Fourmaux E Gain P Ponthieux A
author_facet	Kodjikian L Lecleire-Collet A Dot C Le Lez ML Baillif S Erginay A Souied E Fourmaux E Gain P Ponthieux A
author_sort	Kodjikian L
title	ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
title_short	ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
title_full	ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
title_fullStr	ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
title_full_unstemmed	ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
title_sort	etoile: real-world evidence of 24 months of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/50aa141a92864c05904cba97ca928361
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ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema

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