Ulbig Michael, Brinkmann Christian Karl, Mirshahi Alireza, Hoerauf Hans, Allmeier Helmut, Machewitz Tobias, Scholz Paula, Keramas Georgios, Khoramnia Ramin
Klinik und Poliklinik für Augenheilkunde der Technischen Universität München, Ismaninger Straße 22, 81675, München, Deutschland.
Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Deutschland.
Ophthalmologie. 2024 Nov;121(11):894-903. doi: 10.1007/s00347-024-02110-9. Epub 2024 Sep 17.
AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion. This article presents 24-month data from the German cohort of treatment-naïve patients with DME.
Treatment-naïve patients (≥ 18 years) with DME were treated with IVT-AFL at the discretion of the physician in clinical practice. The primary endpoint was mean change in visual acuity (early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Statistical analyses were descriptive.
The analysis included data from 150 DME patients (54.7% male). At months 6, 12 and 24, mean (95% confidence interval) visual acuity gains of 4.6 (2.6; 6.5), 4.0 (2.1; 6.5) and 5.0 (3.0; 6.9) letters from baseline (mean ±SD: 65.0 ± 15.3 letters) and reductions in retinal thickness of 86µm (109; 64µm), 70µm (94; 43µm) and 75µm (103; 47µm) from baseline (mean ±SD: 391 ± 132 µm), respectively, were achieved. At month 24, 54% of patients gained ≥ 5 letters and 22% ≥ 15 letters. Patients received a mean number of 5.0 ± 1.6 injections until month 6, 7.1 ± 3.2 until month 12 and 9.0 ± 5.3 until month 24, 68% of patients received ≥ 5 injections until month 6 and 56% ≥ 7 injections within the first year. The safety profile was consistent with previous studies.
In the German AURIGA cohort, treatment-naïve DME patients achieved a clinically relevant gain in visual acuity as well as reduction in central retinal thickness following IVT-AFL treatment in clinical practice. From month 6 onwards, improvements were maintained despite a low injection frequency over 24 months. In comparison with previous real-world studies, care of DME patients in clinical practice seems to have improved; however, there is still room for further improvement.
AURIGA是评估玻璃体内注射阿柏西普（IVT-AFL）治疗糖尿病性黄斑水肿（DME）和视网膜静脉阻塞继发黄斑水肿的最大规模前瞻性真实世界研究。本文展示了来自德国初治DME患者队列的24个月数据。
在临床实践中，由医生自行决定对初治的DME患者（≥18岁）采用IVT-AFL治疗。主要终点是与基线相比，第12个月时视力（早期治疗糖尿病性视网膜病变，ETDRS，字母数）的平均变化。统计分析为描述性分析。
分析纳入了150例DME患者的数据（男性占54.7%）。在第6、12和24个月时，与基线（平均值±标准差：65.0±15.3个字母）相比，视力平均提高（95%置信区间）分别为4.6（2.6；6.5）、4.0（2.1；6.5）和5.0（3.0；6.9）个字母，视网膜厚度从基线（平均值±标准差：391±132μm）分别减少86μm（109；64μm）、70μm（94；43μm）和75μm（103；47μm）。在第24个月时，54%的患者视力提高≥5个字母，22%的患者提高≥15个字母。患者在第6个月时平均注射次数为5.0±1.6次，第12个月时为7.1±3.2次，第24个月时为9.0±5.3次；68%的患者在第6个月时接受≥5次注射，56%的患者在第一年内接受≥7次注射。安全性概况与先前研究一致。
在德国AURIGA队列中，初治的DME患者在临床实践中接受IVT-AFL治疗后，视力获得了具有临床意义的提高，中央视网膜厚度也有所减少。从第6个月起，尽管在24个月内注射频率较低，但视力仍保持改善。与先前的真实世界研究相比，临床实践中对DME患者的治疗似乎有所改善；然而，仍有进一步改善的空间。
