Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland

Albert J Augustin,1 Matthias D Becker,2,3 Katja Hatz,4 Hakan Kaymak,5 Andrew Shirlaw6 1Eye Care Clinic, Karlsruhe, Germany; 2Department of Ophthalmology, Zurich City Hospital, Zurich, Switzerland; 3Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany; 4Vista Klinik Binningen, S...

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Autores principales:	Augustin AJ, Becker MD, Hatz K, Kaymak H, Shirlaw A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	diabetic macular edema dme real-world setting safety drug effectiveness Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/c4a4f13f06b748afa25c5f624f49d2cd
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spelling	oai:doaj.org-article:c4a4f13f06b748afa25c5f624f49d2cd2021-12-02T18:09:45ZAssessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland1177-5483https://doaj.org/article/c4a4f13f06b748afa25c5f624f49d2cd2021-09-01T00:00:00Zhttps://www.dovepress.com/assessment-of-reinjection-numbers-and-intervals-for-diabetic-macular-e-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Albert J Augustin,1 Matthias D Becker,2,3 Katja Hatz,4 Hakan Kaymak,5 Andrew Shirlaw6 1Eye Care Clinic, Karlsruhe, Germany; 2Department of Ophthalmology, Zurich City Hospital, Zurich, Switzerland; 3Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany; 4Vista Klinik Binningen, Switzerland and Faculty of Medicine, University of Basel, Basel, Switzerland; 5MVZ Macula and Retina Center Breyer, Kaymak, Klabe, Duesseldorf, Germany; 6Allergan, an AbbVie company, Marlow, Buckinghamshire, UKCorrespondence: Albert J Augustin Moltkestraße 90, Karlsruhe, 76133, GermanyTel +49 721-9742001Email albertjaugustin@googlemail.comPurpose: The purpose was to assess the number and intervals of dexamethasone intravitreal implant (DEX) reinjections in a real-world setting for the treatment of diabetic macular edema (DME) and to determine the relationship with effectiveness and safety.Patients and Methods: Data were abstracted from medical records of DME patients in Germany and Switzerland for this retrospective, multicenter, drug utilization study. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes 7− 12 weeks post-injection(s) measured effectiveness. Adverse events (AEs) of special interest were reported.Results: A total of 141 patients, 108 from Germany and 33 from Switzerland, were assessed. Mean (SD) reinjection interval was 5.7 (4.2) months. Mean baseline BCVA was 61.6 letters, and mean baseline CRT was 413.3 μm. The mean BCVA and CRT changes at 7− 12 weeks after baseline, reinjection 1, 2, and 3 were +3.4, +3.7, +3.2, and − 1.4 letters and − 88.3, − 81.6, − 102.4, and − 124.1 μm, respectively. The Spearman correlation between change in BCVA and CRT and DEX reinjection interval was r=0.03 (P=0.66) and r=0.07 (P=0.38), respectively. Only 18% of patients experienced at least 1 AE.Conclusion: There was no statistically significant correlation between drug effectiveness and reinjection intervals in either country. Although these results are preliminary, they indicate that DEX improves BCVA and CRT in real-world clinical practice.Keywords: diabetic macular edema, DME, real-world setting, safety, drug effectivenessAugustin AJBecker MDHatz KKaymak HShirlaw ADove Medical Pressarticlediabetic macular edemadmereal-world settingsafetydrug effectivenessOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3957-3967 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	diabetic macular edema dme real-world setting safety drug effectiveness Ophthalmology RE1-994
spellingShingle	diabetic macular edema dme real-world setting safety drug effectiveness Ophthalmology RE1-994 Augustin AJ Becker MD Hatz K Kaymak H Shirlaw A Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
description	Albert J Augustin,1 Matthias D Becker,2,3 Katja Hatz,4 Hakan Kaymak,5 Andrew Shirlaw6 1Eye Care Clinic, Karlsruhe, Germany; 2Department of Ophthalmology, Zurich City Hospital, Zurich, Switzerland; 3Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany; 4Vista Klinik Binningen, Switzerland and Faculty of Medicine, University of Basel, Basel, Switzerland; 5MVZ Macula and Retina Center Breyer, Kaymak, Klabe, Duesseldorf, Germany; 6Allergan, an AbbVie company, Marlow, Buckinghamshire, UKCorrespondence: Albert J Augustin Moltkestraße 90, Karlsruhe, 76133, GermanyTel +49 721-9742001Email albertjaugustin@googlemail.comPurpose: The purpose was to assess the number and intervals of dexamethasone intravitreal implant (DEX) reinjections in a real-world setting for the treatment of diabetic macular edema (DME) and to determine the relationship with effectiveness and safety.Patients and Methods: Data were abstracted from medical records of DME patients in Germany and Switzerland for this retrospective, multicenter, drug utilization study. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes 7− 12 weeks post-injection(s) measured effectiveness. Adverse events (AEs) of special interest were reported.Results: A total of 141 patients, 108 from Germany and 33 from Switzerland, were assessed. Mean (SD) reinjection interval was 5.7 (4.2) months. Mean baseline BCVA was 61.6 letters, and mean baseline CRT was 413.3 μm. The mean BCVA and CRT changes at 7− 12 weeks after baseline, reinjection 1, 2, and 3 were +3.4, +3.7, +3.2, and − 1.4 letters and − 88.3, − 81.6, − 102.4, and − 124.1 μm, respectively. The Spearman correlation between change in BCVA and CRT and DEX reinjection interval was r=0.03 (P=0.66) and r=0.07 (P=0.38), respectively. Only 18% of patients experienced at least 1 AE.Conclusion: There was no statistically significant correlation between drug effectiveness and reinjection intervals in either country. Although these results are preliminary, they indicate that DEX improves BCVA and CRT in real-world clinical practice.Keywords: diabetic macular edema, DME, real-world setting, safety, drug effectiveness
format	article
author	Augustin AJ Becker MD Hatz K Kaymak H Shirlaw A
author_facet	Augustin AJ Becker MD Hatz K Kaymak H Shirlaw A
author_sort	Augustin AJ
title	Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
title_short	Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
title_full	Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
title_fullStr	Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
title_full_unstemmed	Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland
title_sort	assessment of reinjection numbers and intervals for diabetic macular edema patients who received dexamethasone intravitreal implants in germany and switzerland
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/c4a4f13f06b748afa25c5f624f49d2cd
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Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland

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