Binder Karoline E, Bleidißel Nathalie, Charbel Issa Peter, Maier Mathias, Coulibaly Leonard M
Department of Ophthalmology, TUM University Hospital, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.
JAMA Ophthalmol. 2025 May 1. doi: 10.1001/jamaophthalmol.2025.0969.
Aflibercept, 8 mg, is an anti-vascular endothelial growth factor (VEGF) formulation for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). While clinical trials report a comparable safety profile as aflibercept, 2 mg, clinical practice setting (so-called real-world) data on the incidence of intraocular inflammation (IOI) should be of value.
To determine the clinical practice setting incidence of IOI after intravitreal injection of aflibercept, 8 mg, for nAMD and DME.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective case series involved a review of medical records at a single tertiary care center. Participants were all patients who received an intravitreal injection of aflibercept, 8 mg, for nAMD or DME from March 2024 to October 2024. Patients had received injections with other VEGF inhibitors before. Standard care included slitlamp examination before each injection and follow-up examination within 4 days after every injection.
IOI adverse events (AEs) after injections.
Incidence of IOI after intravitreal injection of aflibercept, 8 mg. Secondary outcomes included the time point of IOI and best-corrected visual acuity (BCVA) during and after recovery of IOI.
Forty-one patients were treated with intravitreal aflibercept, 8 mg, injections: 23 with nAMD (56%) and 18 with DME (44%). Twenty-seven patients (66%) were male and 14 patients female (34%). A total of 136 intravitreal injections of aflibercept, 8 mg, were administered during the observation period. Five patients of 41 developed mild sterile IOI within 1 to 3 days after the intervention (incidence per injection, 3.7%; 95% CI, 1.6%-8.3%; incidence per patient, 12%; 95% CI, 5.3%-25.5%). Four patients had prior exposure to aflibercept, 8 mg, before the inflammation occurred; only 1 patient developed inflammation after the first dose. All patients were treated with local anti-inflammatory therapy (topical or subconjunctival corticosteroids), and 2 patients received additional systemic oral corticosteroids. No reduction of BCVA was observed after IOI-associated AEs receded.
This analysis in a clinical practice setting revealed a more frequent occurrence of IOI-associated AEs compared with previous clinical trials. All observed cases showed a mild IOI, which resolved under anti-inflammatory therapy without loss of BCVA.
8毫克阿柏西普是一种用于治疗新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）的抗血管内皮生长因子（VEGF）制剂。虽然临床试验报告称其安全性与2毫克阿柏西普相当，但关于眼内炎症（IOI）发生率的临床实践（即所谓的真实世界）数据应具有参考价值。
确定玻璃体内注射8毫克阿柏西普治疗nAMD和DME后在临床实践中的IOI发生率。
设计、设置和参与者：本回顾性病例系列研究对一家三级医疗中心的病历进行了回顾。参与者为2024年3月至2024年10月期间接受玻璃体内注射8毫克阿柏西普治疗nAMD或DME的所有患者。这些患者之前曾接受过其他VEGF抑制剂注射。标准护理包括每次注射前进行裂隙灯检查以及每次注射后4天内进行随访检查。
注射后发生的IOI不良事件（AE）。
玻璃体内注射8毫克阿柏西普后的IOI发生率。次要结局包括IOI的时间点以及IOI恢复期间及之后的最佳矫正视力（BCVA）。
41例患者接受了玻璃体内8毫克阿柏西普注射治疗：23例为nAMD患者（56%），18例为DME患者（44%）。27例患者（66%）为男性，14例患者（34%）为女性。在观察期内共进行了136次玻璃体内8毫克阿柏西普注射。41例患者中有5例在干预后1至3天内发生轻度无菌性IOI（每次注射的发生率为3.7%；95%置信区间为1.6%-8.3%；每位患者的发生率为12%；95%置信区间为5.3%-25.5%）。4例患者在炎症发生前曾接触过8毫克阿柏西普；只有1例患者在首次给药后发生炎症。所有患者均接受了局部抗炎治疗（局部或结膜下使用皮质类固醇），2例患者还接受了额外的全身性口服皮质类固醇治疗。IOI相关不良事件消退后未观察到BCVA下降。
本临床实践环境中的分析显示，与先前的临床试验相比，IOI相关不良事件的发生更为频繁。所有观察到的病例均表现为轻度IOI，在抗炎治疗下得以缓解，且BCVA未丧失。
