Giocanti-Aurégan Audrey, Donati Simone, Hoerauf Hans, Allmeier Helmut, Rittenhouse Kay D, Machewitz Tobias, Yang Chang-Hao
Department of Ophthalmology, Hôpital Avicenne, Sorbonne Paris Nord University, AP-HP, 125 Rue de Stalingrad, Cedex 93009, Bobigny, France.
Department of Medicine and Surgery, University of Insubria, Varese, Italy.
Ophthalmol Ther. 2024 Jan;13(1):179-203. doi: 10.1007/s40123-023-00830-w. Epub 2023 Nov 4.
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.
AURIGA是迄今为止规模最大的一项真实世界研究，旨在评估在常规临床实践中玻璃体内注射阿柏西普（IVT-AFL）治疗糖尿病性黄斑水肿或视网膜静脉阻塞（RVO）继发的黄斑水肿的效果。在此，我们报告来自法国、德国、意大利和台湾地区的RVO队列的24个月研究结果。
AURIGA（NCT03161912）是一项前瞻性观察性研究。符合条件的RVO患者已由主治医生做出接受IVT-AFL治疗的决定并被纳入研究。根据当地的医疗实践，医生可自行决定为患者进行长达24个月的IVT-AFL治疗。主要终点是从基线到第12个月（M12）时视力（VA；早期糖尿病性视网膜病变研究[ETDRS]字母）的平均变化。所有统计分析均为描述性分析。
在554例初治和65例既往接受过治疗的RVO患者中，到M12时，初治患者和既往接受过治疗的患者从基线时VA的平均（95%置信区间）变化分别为+12.5（10.8，14.3）和+7.9（3.3，12.6）个字母，到M24时分别为+11.4（9.4，13.3）和+4.4（-0.6，9.5）个字母（基线平均值±标准差：51.0±21.9和51.9±20.4个字母）；到M24时，44.0%的初治患者和27.9%的既往接受过治疗的患者报告视力提高≥15个字母。到M24时，初治患者视网膜中央厚度相对于基线的平均变化为-247（-267，-227）µm，既往接受过治疗的患者为-147（-192，-102）µm。从基线到M6、M12和M24，初治患者分别总共接受了4.0±1.3、5.5±2.5和6.9±4.2次注射，既往接受过治疗的患者分别接受了3.8±1.5、5.0±2.2和6.3±3.7次注射。IVT-AFL的安全性与既往研究一致。
在AURIGA研究中，RVO患者在常规临床实践中接受IVT-AFL治疗后，在功能和解剖学方面都有临床相关的改善。在24个月的研究中，尽管治疗频率降低，但这些改善在初治患者中大多得以维持，这表明IVT-AFL治疗效果具有长期持久性。本文提供信息图表。
ClinicalTrials.gov标识符：NCT03161912（2017年5月19日）。信息图表。
