Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study.
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
Journal
Ophthalmology and therapy
ISSN: 2193-8245
Titre abrégé: Ophthalmol Ther
Pays: England
ID NLM: 101634502
Informations de publication
Date de publication:
04 Nov 2023
04 Nov 2023
Historique:
received:
31
05
2023
accepted:
29
09
2023
medline:
4
11
2023
pubmed:
4
11
2023
entrez:
4
11
2023
Statut:
aheadofprint
Résumé
AURIGA 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. AURIGA (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. In 554 treatment-naïve 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-naïve 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) µm in treatment-naïve patients and - 147 (- 192, - 102) µm in previously treated patients. From baseline to M6, M12, and M24, treatment-naïve 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. In 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-naïve 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. ClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017). INFOGRAPHIC.
Identifiants
pubmed: 37924481
doi: 10.1007/s40123-023-00830-w
pii: 10.1007/s40123-023-00830-w
doi:
Banques de données
ClinicalTrials.gov
['NCT03161912']
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2023. The Author(s).
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