Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study

OPHTHALMOLOGY AND THERAPY(2024)

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IntroductionAURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Here, we report the 24-month outcomes in the RVO cohort from France, Germany, Italy, and Taiwan.MethodsAURIGA (NCT03161912) was a prospective observational study. Eligible patients with RVO were enrolled for whom the decision to treat with IVT-AFL had already been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month (M) 12. All statistical analyses were descriptive.ResultsIn 554 treatment-naive and 65 previously treated patients with RVO, the respective mean (95% confidence interval) change in VA from baseline was + 12.5 (10.8, 14.3) and + 7.9 (3.3, 12.6) letters by M12 and + 11.4 (9.4, 13.3) and + 4.4 (- 0.6, 9.5) letters by M24 (baseline mean +/- standard deviation: 51.0 +/- 21.9 and 51.9 +/- 20.4 letters); 44.0% of treatment-naive and 27.9% of previously treated patients reported >= 15-letter gains by M24. By M24, the mean change in central retinal thickness from baseline was - 247 (- 267, - 227) mu m in treatment-naive patients and - 147 (- 192, - 102) mu m in previously treated patients. From baseline to M6, M12, and M24, treatment-naive patients received a total of 4.0 +/- 1.3, 5.5 +/- 2.5, and 6.9 +/- 4.2 injections, respectively, and previously treated patients received 3.8 +/- 1.5, 5.0 +/- 2.2, and 6.3 +/- 3.7 injections, respectively. The safety profile of IVT-AFL was consistent with that of previous studies.ConclusionsIn AURIGA, patients with RVO experienced clinically relevant functional and anatomic improvements following IVT-AFL treatment in routine clinical practice. These improvements were largely maintained in treatment-naive patients over the 24-month study despite the decreasing treatment frequency, suggesting long-term durability of IVT-AFL treatment outcomes. Infographic available for this article.Trial RegistrationClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017).
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关键词
Anti-vascular endothelial growth factor,Branch retinal vein occlusion,Central retinal vein occlusion,Intravitreal aflibercept,Macular edema,Observational study,Optical coherence tomography,Real-world evidence,Retinal disease,Retinal vein occlusion
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