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Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study

Graefe's archive for clinical and experimental ophthalmology, 2020-03, Vol.258 (3), p.521-528 [Peer Reviewed Journal]

The Author(s) 2019 ;Graefe's Archive for Clinical and Experimental Ophthalmology is a copyright of Springer, (2019). All Rights Reserved. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Attribution ;ISSN: 0721-832X ;EISSN: 1435-702X ;DOI: 10.1007/s00417-019-04592-9 ;PMID: 31894377

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Title:
Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study
Author: Korobelnik, Jean-François ; Daien, Vincent ; Faure, Céline ; Tadayoni, Ramin ; Giocanti-Auregan, Audrey ; Dot, Corinne ; Kodjikian, Laurent ; Massin, Pascale
Subjects: Acuity ; Aged ; Diabetes ; Diabetes mellitus ; Diabetic retinopathy ; Diabetic Retinopathy - complications ; Diabetic Retinopathy - drug therapy ; Diabetic Retinopathy - epidemiology ; Edema ; Female ; Follow-Up Studies ; France - epidemiology ; Human health and pathology ; Humans ; Incidence ; Intravitreal Injections ; Life Sciences ; Macular Edema - drug therapy ; Macular Edema - epidemiology ; Macular Edema - etiology ; Male ; Medicine ; Medicine & Public Health ; Ophthalmology ; Patients ; Pharmaceutical sciences ; Pharmacology ; Prospective Studies ; Receptors, Vascular Endothelial Growth Factor - administration & dosage ; Recombinant Fusion Proteins - administration & dosage ; Retina ; Retinal Disorders ; Retinopathy ; Santé publique et épidémiologie ; Sensory Organs ; Steroid hormones ; Time Factors ; Treatment Outcome ; Vascular endothelial growth factor ; Visual Acuity
Is Part Of: Graefe's archive for clinical and experimental ophthalmology, 2020-03, Vol.258 (3), p.521-528
Description: Purpose To report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice. Methods APOLLON (NCT02924311) was a prospective, observational cohort study of patients with DME. Effectiveness was evaluated by change from baseline in best-corrected visual acuity (BCVA) at 12 months in treatment-naïve patients (i.e., had not received any anti-vascular endothelial growth factor [anti-VEGF] agent, laser, or steroid at IVT-AFL treatment start) and previously treated patients (i.e., previously treated with anti-VEGF agents other than IVT-AFL, laser, or steroids at IVT-AFL treatment start). Secondary endpoints included change in central retinal thickness (CRT) over 12 months, frequency of injections, and proportion of patients with safety events. Results Of the 147 patients followed for at least 12 months and included in the effectiveness analysis, 52.4% ( n = 77) were treatment-naïve and 47.6% ( n = 70) were previously treated. Mean (standard deviation [SD]) BCVA score at baseline was 62.7 (14.3) Early Treatment Diabetic Retinopathy Study (ETDRS) letters in treatment-naïve patients and 60.0 (13.7) ETDRS letters in previously treated patients. At month 12, mean (SD) change in BCVA was + 7.8 (12.3) letters in treatment-naïve patients and + 5.0 (11.3) letters in previously treated patients. Mean CRT decreased in both patient cohorts. The mean (SD) number of IVT-AFL injections at month 12 was 7.6 (2.5) for treatment-naïve patients and 7.6 (2.3) for previously treated patients. Of 388 patients included in the safety analysis, ocular treatment-emergent adverse events occurred in 54.1% ( n = 210) of patients. Conclusion IVT-AFL treatment was associated with improvements in functional and anatomic outcomes in both treatment-naïve and previously treated patients with DME in France.
Publisher: Berlin/Heidelberg: Springer Berlin Heidelberg
Language: English
Identifier: ISSN: 0721-832X
EISSN: 1435-702X
DOI: 10.1007/s00417-019-04592-9
PMID: 31894377
Source: Hyper Article en Ligne (HAL) (Open Access)
MEDLINE
Springer Nature OA/Free Journals
ProQuest Central

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Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study

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