[Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept]. / Aflibercept im klinischen Alltag: die AURIGA-Studie : 24-Monats-Ergebnisse der deutschen Kohorte behandlungsnaiver Patienten mit Makulaödem bei retinalem Venenverschluss unter Therapie mit intravitrealem Aflibercept.
Ophthalmologie
; 121(8): 650-657, 2024 Aug.
Article
en De
| MEDLINE
| ID: mdl-38976039
ABSTRACT
BACKGROUND:
AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2â¯mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO.METHODS:
Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2â¯mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Analyses were descriptive.RESULTS:
Analysis included 130 patients with RVO (nâ¯= 61, 46.9% with central RVO, nâ¯= 69, 53.1% with branch RVO). The mean (± SD) time the RVO patients remained in the study was 18.4⯱ 7.4 months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month 12 and +9.7 (6.1-13.3) at month 24 (baseline VA 56.5⯱ 18.9 letters). At 24 months, 67% of RVO patients gained ≥5 letters and 40% gained ≥15 letters. The mean number of injections was 4.4⯱ 1.3 up to month 6, 6.2⯱ 2.7 up to month 12 and 8.2⯱ 4.5 up to month 24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12 months and -219µm (-263 to -175µm) at 24 months (baseline CRT 507⯱ 177⯵m). The safety profile was consistent with that of previous studies.DISCUSSION:
In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2â¯mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and a reduction in CRT. These results were largely maintained over 24 months despite the low injection frequency from month 6.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Proteínas Recombinantes de Fusión
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Oclusión de la Vena Retiniana
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Agudeza Visual
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Edema Macular
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Receptores de Factores de Crecimiento Endotelial Vascular
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Inyecciones Intravítreas
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Europa
Idioma:
De
Revista:
Ophthalmologie
Año:
2024
Tipo del documento:
Article