Palm Christiane, Zweifel Sandrine Anne, Gabathuler Felix, Cozzi Mariano, Fasler Katrin
Department of Ophthalmology, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.
Eye Clinic, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan, 20157 Milan, Italy.
J Clin Med. 2025 Jul 10;14(14):4900. doi: 10.3390/jcm14144900.
This study aims to evaluate the real-world efficacy and safety of aflibercept 8 mg intravitreal injections (IVTs) in pretreated patients with neovascular age-related macular degeneration (nAMD) throughout the first three IVTs. : Established anti-vascular-endothelial-growth-factor (anti-VEGF) therapies positively impact the progression of nAMD but require frequent administration, thus burdening patients and the healthcare system. Pivotal trials of the recently approved aflibercept 8 mg have demonstrated extended dosing intervals with comparable safety to standard treatments. However, real-world data is still scarce. : A retrospective, single-center single-arm analysis was conducted on 22 eyes from 18 pretreated nAMD patients. Eyes were switched from other anti-VEGF agents to aflibercept 8 mg injections continuing a treat-and-extend regimen (no loading dose after switching). Treatment intervals and structural (central subfield thickness (CST); disease activity) and functional (best corrected visual acuity (BCVA)) outcomes were assessed at baseline (date of first aflibercept 8 mg injection) and at follow-up examinations until follow-up 3. Safety data, including intraocular pressure changes, were recorded. : Over a median follow-up of 16.6 weeks (IQR 15.1-27.0), patients switched to aflibercept 8 mg showed prolonged intervals between injections (5.5 weeks vs. 7 weeks, < 0.001, Wilcoxon signed-rank test), reduced disease activity, stable CST, and stable BCVA. One patient experienced transient intraocular pressure elevation, which resolved without intervention. No other adverse events were observed. : Treatment with aflibercept 8 mg appears to provide effective disease control with prolonged treatment intervals in switched nAMD patients in routine clinical practice. These findings further indicate the potential for reducing treatment burden.
本研究旨在评估阿柏西普8毫克玻璃体内注射（IVT）在前瞻性治疗的新生血管性年龄相关性黄斑变性（nAMD）患者接受首次三次IVT治疗期间的真实疗效和安全性。：已确立的抗血管内皮生长因子（抗VEGF）疗法对nAMD的进展有积极影响，但需要频繁给药，从而给患者和医疗系统带来负担。最近批准的阿柏西普8毫克的关键试验表明，给药间隔延长，安全性与标准治疗相当。然而，真实世界的数据仍然很少。：对18例接受过治疗的nAMD患者的22只眼睛进行了回顾性单中心单臂分析。将眼睛从其他抗VEGF药物转换为阿柏西普8毫克注射，继续采用治疗并延长方案（转换后无负荷剂量）。在基线（首次注射阿柏西普8毫克的日期）和随访检查直至随访3时，评估治疗间隔以及结构（中心子区域厚度（CST）；疾病活动度）和功能（最佳矫正视力（BCVA））结果。记录包括眼压变化在内的安全性数据。：在中位随访期16.6周（四分位间距15.1 - 27.0）内，转换为阿柏西普8毫克的患者注射间隔延长（5.5周对7周，<0.001，Wilcoxon符号秩检验），疾病活动度降低，CST稳定，BCVA稳定。1例患者出现短暂眼压升高，未经干预即缓解。未观察到其他不良事件。：在常规临床实践中，对转换治疗的nAMD患者使用阿柏西普8毫克治疗似乎能有效控制疾病，延长治疗间隔。这些发现进一步表明了减轻治疗负担的潜力。
