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雷珠单抗生物类似药治疗继发于湿性年龄相关性黄斑变性(nAMD)和息肉状脉络膜血管病变(PCV)的黄斑新生血管后,基于频域光学相干断层扫描(En-face OCT)的最小强度液体变化的定量评估

Quantitative Assessment of En‑face OCT‑Derived Minimum Intensity Fluid Changes Following Ranibizumab Biosimilar Therapy in Macular Neovascularization Secondary to nAMD and PCV.

作者信息

Sheth Jay Umed, Bhopalka Ankit Kumar, Meshram Bhagyashree, Karande Sayali

机构信息

Department of Retina Services, Shantilal Shanghvi Eye Institute, Mumbai, India.

Department of Retina Services, Katihar Satyabhama Netralaya, Katihar, India.

出版信息

Clin Ophthalmol. 2025 Jul 29;19:2505-2512. doi: 10.2147/OPTH.S542496. eCollection 2025.

Abstract

PURPOSE

This retrospective study aimed to evaluate the efficacy of a new regulatory approved ranibizumab biosimilar (RzB), Oceva (Sun Pharmaceutical Industries Limited, Mumbai, India), in treating macular neovascularization secondary to neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV), using Minimum-Intensity based changes observed on en-face optical coherence tomography (OCT) (en-face MI OCT).

PATIENTS AND METHODS

Thirty-six eyes with treatment-naïve MNV underwent three loading doses of RzB. Best-corrected visual acuity (BCVA) and the proportions of eyes with subretinal fluid (SRF), intraretinal fluid (IRF), and subretinal hyperreflective material (SHRM) were assessed. En-face MI OCT-based analysis was conducted to quantify changes in fluid area and perimeter.

RESULTS

At 12 weeks, there was a statistically significant improvement in BCVA from 0.94 {≈20/174} (± 0.59) logMAR to 0.84 {≈20/138} (± 0.61) logMAR (=0.04). En-face MI OCT revealed a significant reduction in the median area of fluid from 0.9 mm² (IQR 0.62-4.56) to 0.32 mm² (IQR 0.1-0.64) (=0.007), and in the median perimeter of fluid from 10.95 mm (IQR 7.26-25.67) to 6.02 mm (IQR 1.76-7.93) (=0.0005). The proportion of eyes with SRF, IRF, and SHRM decreased from baseline (83.33%, 66.67%, and 58.33% respectively) to 12 weeks (58.33% [0.015], 38.89% [0.013], and 13.89% [P<0.001]). No adverse events were reported.

CONCLUSION

Treatment with the novel RzB showed promising outcomes in improving visual parameters and reducing fluid accumulation in patients with MNV secondary to nAMD and PCV. Minimum Intensity-based analysis provided detailed insights into fluid dynamics, demonstrating its utility in evaluating treatment responses in MNV. This study contributes to the initial assessment of RzB in clinical practice, highlighting its potential efficacy in managing MNV.

摘要

目的

本回顾性研究旨在评估一种新的监管批准的雷珠单抗生物类似药(RzB),Oceva(印度孟买太阳制药工业有限公司),在治疗继发于新生血管性年龄相关性黄斑变性(nAMD)和息肉状脉络膜血管病变(PCV)的黄斑新生血管(MNV)方面的疗效,采用基于最小强度变化的正面光学相干断层扫描(OCT)(正面MI OCT)观察。

患者和方法

36只初治MNV眼接受了3次RzB负荷剂量治疗。评估最佳矫正视力(BCVA)以及视网膜下液(SRF)、视网膜内液(IRF)和视网膜下高反射物质(SHRM)的眼比例。进行基于正面MI OCT的分析以量化液体积聚面积和周长的变化。

结果

在12周时,BCVA从0.94{≈20/174}(±0.59)logMAR有统计学显著改善至0.84{≈20/138}(±0.61)logMAR(P = 0.04)。正面MI OCT显示液体积聚的中位数面积从0.9平方毫米(四分位间距0.62 - 4.56)显著减少至0.32平方毫米(四分位间距0.1 - 0.64)(P = 0.007),液体积聚的中位数周长从10.95毫米(四分位间距7.26 - 25.67)减少至6.02毫米(四分位间距1.76 - 7.93)(P = 0.0005)。有SRF、IRF和SHRM的眼比例从基线(分别为83.33%、66.67%和58.33%)降至12周时(分别为58.33%[P = 0.015]、38.89%[P = 0.013]和13.89%[P<0.001])。未报告不良事件。

结论

新型RzB治疗在改善nAMD和PCV继发MNV患者的视觉参数及减少液体积聚方面显示出有前景的结果。基于最小强度的分析为液体积聚动力学提供了详细见解,证明了其在评估MNV治疗反应中的效用。本研究有助于在临床实践中对RzB进行初步评估,突出了其在管理MNV方面的潜在疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ae/12319160/f84e9985c53b/OPTH-19-2505-g0001.jpg

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