Abstract
PurposeTo report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice.MethodsAPOLLON (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.ResultsOf 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.ConclusionIVT-AFL treatment was associated with improvements in functional and anatomic outcomes in both treatment-naïve and previously treated patients with DME in France.
Highlights
Diabetic macular edema (DME) is a complication of diabetic retinopathy and manifests as retinal thickening from the accumulation of intraretinal fluid (IRF) caused by failure of the blood–retinal barrier [1]
Anti-vascular endothelial growth factor agents, such as intravitreal aflibercept (IVT-AFL) and ranibizumab, are recommended as first-line therapy for DME [1]; their use is based on the observation that VEGF levels are increased in the retina of patients with retinopathies and that VEGF acts as an important mediator of the blood– retinal barrier breakdown [5, 6]
Of the 402 patients with DME enrolled in the study, 374 patients were included in the full analysis set and 388 patients were included in the safety analysis (Fig. 1)
Summary
Diabetic macular edema (DME) is a complication of diabetic retinopathy and manifests as retinal thickening from the accumulation of intraretinal fluid (IRF) caused by failure of the blood–retinal barrier [1]. The Wisconsin Epidemiologic Study of Diabetic Retinopathy reported that the incidence of DME in patients with type 1 or type 2 diabetes doubled within 5–6 years of disease diagnosis [4]. Anti-vascular endothelial growth factor (anti-VEGF) agents, such as intravitreal aflibercept (IVT-AFL) and ranibizumab, are recommended as first-line therapy for DME [1]; their use is based on the observation that VEGF levels are increased in the retina of patients with retinopathies and that VEGF acts as an important mediator of the blood– retinal barrier breakdown [5, 6]. Real-world studies are useful in showing the effectiveness of anti-VEGF agents in DME management in current clinical settings
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