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法西单抗治疗脉络膜视网膜疾病的真实世界研究结果:印度真实世界分析(FOCUS研究)

Faricimab Outcomes in Chorioretinal Disorders: Indian Real-World Analysis (FOCUS Study).

作者信息

Agrawal Vishal, Gupta Ayushi, Agrawal Virendra, Sheth Jay Umed

机构信息

Department of Retina, Agrawal Hospital, Jaipur, India.

Department of Retina, Dr. Virendra Laser Phaco Surgery Centre, Jaipur, Rajasthan, India.

出版信息

Clin Ophthalmol. 2025 Jun 12;19:1855-1862. doi: 10.2147/OPTH.S521384. eCollection 2025.

Abstract

PURPOSE

To assess the real-world efficacy and safety of intravitreal faricimab in treating Diabetic Macular Edema (DME), neovascular Age-related Macular Degeneration (nAMD), and Central Macular Edema (CME) secondary to retinal vein occlusion (RVO) in an Indian population.

PATIENTS AND METHODS

This single‑center, retrospective observational study reviewed the records of 49 patients (49 eyes) diagnosed with DME, nAMD, or cystoid macular edema secondary to RVO, who received a total of 150 intravitreal faricimab injections and were followed for at least 24 weeks. Patients received intravitreal faricimab injections, with follow-up at four-week intervals. Outcome measures included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), along with resolution of intraretinal (IRF) and subretinal fluid (SRF) in nAMD patients.

RESULTS

Faricimab significantly improved BCVA and reduced CMT across all groups after a mean follow-up period of 33.31 (± 7.41) weeks. DME patients' BCVA improved from 0.71 (± 0.36) LogMAR to 0.46 (± 0.35) LogMAR (<0.0001), nAMD from 1.24 (± 0.73) to 0.43 (± 0.43) LogMAR (=0.00003), and RVO from 0.78 (± 0.32) to 0.38 (± 24) LogMAR (=0.02). CMT decreased from 454.43 (± 164.76) µm to 255.3 (± 81.17) µm (<0.00001) overall. Significant reductions were also observed in IRF and SRF in nAMD patients, with IRF decreasing from 48% to 16% (=0.008) and SRF from 100% to 20% (<0.00001). No significant adverse events, including intraocular inflammation (IOI), were reported.

CONCLUSION

Faricimab demonstrated significant visual and anatomical improvements across all diagnostic groups, including off‑label use in RVO‑associated CME during the study period, showing promise as an effective treatment for DME, nAMD, and RVO. These real-world outcomes align with clinical trial data (TENAYA, LUCERNE, YOSEMITE, RHINE), underscoring faricimab's potential as an effective, dual-action therapy for chorioretinal disorders.

摘要

目的

评估玻璃体内注射法西单抗在治疗印度人群糖尿病性黄斑水肿(DME)、新生血管性年龄相关性黄斑变性(nAMD)以及视网膜静脉阻塞(RVO)继发的中心性黄斑水肿(CME)方面的真实世界疗效和安全性。

患者与方法

本单中心回顾性观察研究回顾了49例(49只眼)诊断为DME、nAMD或RVO继发的黄斑囊样水肿患者的记录,这些患者共接受了150次玻璃体内法西单抗注射,并随访至少24周。患者接受玻璃体内法西单抗注射,每四周进行一次随访。观察指标包括最佳矫正视力(BCVA)和中心黄斑厚度(CMT)的变化,以及nAMD患者视网膜内液(IRF)和视网膜下液(SRF)的消退情况。

结果

在平均33.31(±7.41)周的随访期后,法西单抗在所有组中均显著改善了BCVA并降低了CMT。DME患者的BCVA从0.71(±0.36)LogMAR提高到0.46(±0.35)LogMAR(<0.0001),nAMD患者从1.24(±0.73)提高到0.43(±0.43)LogMAR(=0.00003),RVO患者从0.78(±0.32)提高到0.38(±24)LogMAR(=0.02)。总体CMT从454.43(±164.76)µm降至255.3(±81.17)µm(<0.00001)。nAMD患者的IRF和SRF也显著降低,IRF从48%降至16%(=0.008),SRF从100%降至20%(<0.00001)。未报告包括眼内炎症(IOI)在内的显著不良事件。

结论

法西单抗在所有诊断组中均显示出显著的视力和解剖学改善,包括在研究期间对RVO相关CME的超适应证使用,显示出有望成为DME、nAMD和RVO的有效治疗方法。这些真实世界的结果与临床试验数据(TENAYA、LUCERNE、YOSEMITE、RHINE)一致,强调了法西单抗作为脉络膜视网膜疾病有效双作用疗法的潜力。

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