Wachtlin Joachim, Kaymak Hakan, Hoerauf Hans, Allmeier Helmut, Machewitz Tobias, Scholz Paula, Schürks Markus, Feltgen Nicolas
Sankt Gertrauden Krankenhaus, Paretzer Str. 12, 10713, Berlin, Deutschland.
MHB, Medizinische Hochschule Brandenburg, Neuruppin, Deutschland.
Ophthalmologie. 2024 Aug;121(8):650-657. doi: 10.1007/s00347-024-02051-3. Epub 2024 Jul 8.
AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 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.
Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 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.
Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 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 µm). The safety profile was consistent with that of previous studies.
In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 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.
AURIGA是一项规模最大的前瞻性真实世界研究，旨在评估玻璃体内注射2毫克阿柏西普（IVT-AFL）治疗视网膜静脉阻塞（RVO）继发的黄斑水肿（ME）和糖尿病性黄斑水肿。在此，我们展示了德国队列中初治RVO继发ME患者的24个月数据。
在常规临床实践中，对初治的RVO继发ME患者采用2毫克IVT-AFL进行治疗。主要终点是与基线相比，第12个月时的视力（VA，早期治疗糖尿病性视网膜病变，ETDRS，字母数）平均变化。分析为描述性分析。
分析纳入了130例RVO患者（n = 61，46.9%为中心性RVO，n = 69，53.1%为分支性RVO）。RVO患者在研究中的平均（±标准差）停留时间为18.4 ± 7.4个月。整个队列在第12个月时的平均视力提高（95%置信区间）为+10.9（7.5 - 14.2）个字母，在第24个月时为+9.7（6.1 - 13.3）个字母（基线视力为56.5 ± 18.9个字母）。在24个月时，67%的RVO患者视力提高≥5个字母，40%的患者视力提高≥15个字母。截至第6个月的平均注射次数为4.4 ± 1.3次，截至第12个月为6.2 ± 2.7次，截至第24个月为8.2 ± 4.5次。在12个月时，平均中心视网膜厚度（CRT）降低-206µm（-252至-160µm），在24个月时降低-219µm（-263至-175µm）（基线CRT为507 ± 177µm）。安全性概况与既往研究一致。
在德国AURIGA队列中，初治的RVO继发ME患者在临床实践中接受2毫克IVT-AFL治疗可使视力迅速且在临床上显著提高，并使CRT降低。尽管从第6个月起注射频率较低，但这些结果在24个月内基本得以维持。
