Twelve-Month Outcomes of Faricimab for Patients with Sub-Optimally Responsive Diabetic Macular Oedema: A Retrospective Single-Centre Study.

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-05-16 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S513009
Kamal El-Badawi, Benjamin Scrivens, Oluwaniyi Eke, Rehab Ismail, Lina Kobayter, Serena Salvatore
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引用次数: 0

Abstract

Purpose: To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.

Patients and methods: This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.

Results: Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (p=0.008), while CST reduced to 372.8 (±132.0) µm (p=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (p=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (p=0.572), and CST reduced further to 343.1 (±117.5) µm (p=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.

Conclusion: DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.

Faricimab治疗次优反应性糖尿病黄斑水肿患者的12个月疗效:一项回顾性单中心研究
目的:评估在12个月的时间里,将对阿非利西贝2mg反应不佳的糖尿病性黄斑水肿(DMO)患者转换为法利昔单抗的视觉和解剖学结果。患者和方法:这项回顾性单中心研究纳入了来自50例糖尿病性黄斑水肿(DMO)患者的62只眼睛,这些患者对阿伯西普2mg的反应不佳。次优反应的定义是中心子场厚度(CST)超过325µm,或者在间隔8周或更短时间内服用阿伯西伯2mg后,中心子场厚度(CST)比最佳CST增加20%以上。患者接受了至少6次2mg阿非利西普,每4周一次。Faricimab以4周间隔进行4次玻璃体内负荷注射,随后采用治疗延长方法。结果测量,包括最佳记录视力(BRVA)、CST和治疗间隔,在基线、加载后(6.5±1.9周)和最新临床回顾(57.1±19.7周)进行评估。统计学分析采用配对t检验(正态分布)和Wilcoxon符号秩检验(非正态分布),以p < 0.05为差异有统计学意义。结果:平均年龄63.9(±11.4)岁,56%为男性。基线时,平均BRVA为67.6(±11.8)个字母,CST为406.4(±105.9)µm。初始平均治疗间隔为6.5(±1.8)周。BRVA增加到70.4(±12.7)个字母(p=0.008), CST降低到372.8(±132.0)µm (p=0.002)。平均注射间隔延长至7.4(±2.6)周(p=0.03)。最新随访时BRVA维持在68.7(±14.6)个字母(p=0.572), CST进一步降低至343.1(±117.5)µm (p=0.020)。在最终随访时,53.2%的患者≥8周。平均注射间隔增加到9.2(±3.2)周(p < 0.001),平均注射7.92(±2.53)次法利西单抗。结论:对阿非利西贝2mg反应不佳的DMO患者在使用法利西单抗维持视力的同时,解剖结果得到改善,治疗间隔延长,没有新的安全性问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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