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8毫克阿柏西普治疗新生血管性年龄相关性黄斑变性的真实世界疗效和安全性:病例系列

Real-world efficacy and safety of 8 mg aflibercept in neovascular AMD: a case series.

作者信息

Sambhara Deepak, Vakharia Priya, Eichenbaum David A

机构信息

Eye Clinic of Wisconsin SC, Wausau, Wisconsin, USA.

Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

出版信息

BMJ Open Ophthalmol. 2025 Feb 13;10(1):e002091. doi: 10.1136/bmjophth-2024-002091.

DOI:10.1136/bmjophth-2024-002091
PMID:39947712
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11831258/
Abstract

OBJECTIVE

This real-world retrospective case series evaluates the safety and efficacy of aflibercept 8 mg in patients diagnosed with neovascular age-related macular degeneration (nAMD).

METHODS AND ANALYSES

Treatment-naïve or treatment-experienced patients with nAMD receiving aflibercept 8 mg with at least 6 months of follow-up were assessed.

RESULTS

40 eyes from 33 patients were included, of which 36/40 eyes were previously treated. The mean age of subjects is 79.84 years. At baseline, 29/36 eyes had intraretinal fluid (IRF)/subretinal fluid (SRF) at an average interval of 40.97 days, logMAR VA of 0.346, and average central subfield thickness (CST) of 341.53 µm. At final follow-up, average logMAR VA was 0.315 and average CST decreased by 39.39 µm, with an average number of days since last treatment of 52.9. Of the 32 eyes with IRF, SRF, or both at the time of switch, 12 eyes achieved anatomical quiescence without IRF/SRF after the first injection of aflibercept 8 mg, including three of four treatment-naive patients.

CONCLUSIONS

This early case series suggests that patients treated with aflibercept 8 mg may achieve greater duration between treatments while preserving and, in some cases, improving visual acuity and anatomical outcomes in a real-world clinic setting. In this retrospective study, the patient population primarily consisted of treatment-experienced cases with recalcitrant disease or high treatment burdens, potentially using aflibercept 8 mg as salvage therapy. This selection bias limits generalisability to broader real-world populations. The small sample size precludes formal statistical conclusions. Multiple investigators made unstandardised treatment decisions based on individual clinical judgement, including whether to continue aflibercept 8 mg or revert to prior therapy, sometimes after just one injection.

摘要

目的

本真实世界回顾性病例系列评估了8毫克阿柏西普在诊断为新生血管性年龄相关性黄斑变性(nAMD)患者中的安全性和有效性。

方法与分析

对初治或曾接受治疗的nAMD患者接受8毫克阿柏西普治疗且随访至少6个月的情况进行评估。

结果

纳入了33例患者的40只眼,其中36/40只眼曾接受过治疗。受试者的平均年龄为79.84岁。基线时,29/36只眼存在视网膜内液(IRF)/视网膜下液(SRF),平均间隔40.97天,logMAR视力为0.346,平均中心子野厚度(CST)为341.53μm。在末次随访时,平均logMAR视力为0.315,平均CST降低了39.39μm,自上次治疗后的平均天数为52.9天。在转换治疗时存在IRF、SRF或两者皆有的32只眼中,12只眼在首次注射8毫克阿柏西普后实现了无IRF/SRF的解剖学静止,其中包括4例初治患者中的3例。

结论

这个早期病例系列表明,在真实世界临床环境中,接受8毫克阿柏西普治疗的患者可能在治疗间隔期间更长,同时保持并在某些情况下提高视力和解剖学结果。在这项回顾性研究中,患者群体主要由患有顽固性疾病或高治疗负担的曾接受治疗的病例组成,可能将8毫克阿柏西普用作挽救治疗。这种选择偏倚限制了对更广泛真实世界人群的普遍性。样本量小排除了得出正式统计结论的可能性。多名研究者基于个人临床判断做出了未标准化的治疗决策,包括是否继续使用8毫克阿柏西普或恢复先前治疗,有时仅在一次注射后。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/a3d38c837d55/bmjophth-10-1-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/2f29b071e9b9/bmjophth-10-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/bfd96ef67675/bmjophth-10-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/a3d38c837d55/bmjophth-10-1-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/2f29b071e9b9/bmjophth-10-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/bfd96ef67675/bmjophth-10-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2166/11831258/a3d38c837d55/bmjophth-10-1-g003.jpg

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