Zhai Gaixia, Sun Chao, Zhang Xia, Su Yuanzhen
Zibo Central Hospital, Zibo, China.
Front Med (Lausanne). 2025 Mar 24;12:1528104. doi: 10.3389/fmed.2025.1528104. eCollection 2025.
This study aimed to evaluate the efficacy and safety of intravitreal injection of aflibercept biosimilar in the treatment of diabetic macular edema (DME).
Clinical data were collected from 33 patients (40 eyes) newly diagnosed with DME in the ophthalmology department of our hospital between February and April 2024, all of whom were treated with the aflibercept biosimilar. Patients were managed according to the 3+ Pro re nata (PRN) regimen and completed a minimum follow-up period of 6 months. The best-corrected visual acuity (BCVA) testing, optical coherence tomography, optical coherence tomography angiography, and multifocal electroretinography were performed before and after treatment. BCVA and central retinal thickness (CRT) were compared at baseline and 1-, 3-, and 6-months post-treatment. Additionally, the changes in the foveal avascular zone area, vascular density (VD) of superficial and deep retinal capillaries in the macular region, and the first positive peak amplitude density in ring 1 were analyzed 6 months post-treatment.
BCVA improved significantly from 0.53 ± 0.12 logMAR at baseline to 0.31 ± 0.12, 0.26 ± 0.10, and 0.26 ± 0.08 logMAR at 1-, 3-, and 6-months post-treatment, respectively, ( < 0.05). CRT decreased significantly from 422.4 ± 63.04 μm at baseline to 294.7 ± 47.89, 272.1 ± 47.43, and 281.0 ± 40.72 μm at 1-, 3-, and 6-months post-treatment, respectively, ( < 0.05). The foveal avascular zone area significantly reduced from 0.40 ± 0.08 mm at baseline to 0.35 ± 0.07 mm at 6 months post-treatment. Superficial VD increased significantly from 38.90 ± 7.88% at baseline to 41.21 ± 7.98% at 6 months post-treatment, while deep VD significantly increased from 35.67 ± 7.50% at baseline to 38.72 ± 6.90% ( < 0.05). The first positive peak amplitude improved significantly from 55.30 ± 9.45 to 72.90 ± 7.44 nv/deg at 6 months post-treatment ( < 0.05).
Intravitreal injections of aflibercept biosimilar can significantly reduce DME, improve BCVA, enhance macular perfusion, and restore macular function.
本研究旨在评估玻璃体内注射阿柏西普生物类似药治疗糖尿病性黄斑水肿（DME）的疗效和安全性。
收集2024年2月至4月期间在我院眼科新诊断为DME的33例患者（40只眼）的临床资料，所有患者均接受阿柏西普生物类似药治疗。患者按照3+按需（PRN）方案进行管理，并完成至少6个月的随访期。在治疗前后进行最佳矫正视力（BCVA）测试、光学相干断层扫描、光学相干断层扫描血管造影和多焦视网膜电图检查。比较基线时以及治疗后1、3和6个月时的BCVA和中心视网膜厚度（CRT）。此外，在治疗后6个月分析黄斑无血管区面积、黄斑区浅层和深层视网膜毛细血管的血管密度（VD）以及环1中第一个正峰振幅密度的变化。
BCVA从基线时的0.53±0.12 logMAR显著改善至治疗后1、3和6个月时分别为0.31±0.12、0.26±0.10和0.26±0.08 logMAR（P<0.05）。CRT从基线时的422.4±63.04μm显著降低至治疗后1、3和6个月时分别为294.7±47.89、272.1±47.43和281.0±40.72μm（P<0.05）。黄斑无血管区面积从基线时的0.40±0.08mm显著减少至治疗后6个月时的0.35±0.07mm。浅层VD从基线时的38.90±7.88%显著增加至治疗后6个月时的41.21±7.98%，而深层VD从基线时的35.67±7.50%显著增加至38.72±6.90%（P<0.05）。治疗后6个月时第一个正峰振幅从55.30±9.45显著改善至72.90±7.44 nv/deg（P<0.05）。
玻璃体内注射阿柏西普生物类似药可显著减轻DME，改善BCVA，增强黄斑灌注，并恢复黄斑功能。
