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Anterior migration of Ozurdex implant: a review on risk factors, complications, and management. Ozurdex种植体前移:危险因素、并发症和处理的综述。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-27 DOI: 10.1186/s40942-023-00513-5
Panagiotis Tsoutsanis, Dimitrios Kapantais

Purpose: To describe the common risk factors, complications, and management options for anterior migration of Ozurdex implant.

Methods: A comprehensive review of the literature was performed.

Results: Amongst the most common risk factors predisposing to implant anterior migration we found a history of pseudophakia or aphakia or previous vitrectomy. The most common complication is that of corneal edema.

Conclusions: A variety of management options to treat migration of the dexamethasone implant are utilized by different specialists around the world. These depend on the doctor's preference, presence of corneal damage and history of previous migrations after repositioning the implant. The most common approaches are operative or non-operative implant repositioning and surgical implant removal.

目的:描述Ozurdex种植体前移的常见危险因素、并发症和处理方案。方法:对相关文献进行综合复习。结果:在导致种植体前移的最常见危险因素中,我们发现有假性晶状体或无晶状体病史或既往玻璃体切除术。最常见的并发症是角膜水肿。结论:世界各地不同的专家采用了多种管理方案来治疗地塞米松植入物的移位。这取决于医生的偏好、角膜损伤的存在以及植入物重新定位后的既往移位史。最常见的方法是手术或非手术植入物重新定位和手术移除植入物。
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引用次数: 0
An update on visual prosthesis. 视觉假体的最新进展。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-23 DOI: 10.1186/s40942-023-00498-1
Kailyn A Ramirez, Laura E Drew-Bear, Maria Vega-Garces, Henry Betancourt-Belandria, J Fernando Arevalo

Purpose: To review the available evidence on the different retinal and visual prostheses for patients with retinitis pigmentosa and new implants for other indications including dry age-related macular degeneration.

Methods: The PubMed, GoogleScholar, ScienceDirect, and ClinicalTrials databases were the main resources used to conduct the medical literature search. An extensive search was performed to identify relevant articles concerning the worldwide advances in retinal prosthesis, clinical trials, status of devices and potential future directions up to December 2022.

Results: Thirteen devices were found to be current and were ordered by stimulation location. Six have active clinical trials. Four have been discontinued, including the Alpha IMS, Alpha AMS, IRIS II, and ARGUS II which had FDA and CE mark approval. Future directions will be presented in the review.

Conclusion: This review provides an update of retinal prosthetic devices, both current and discontinued. While some devices have achieved visual perception in animals and/or humans, the main issues impeding the commercialization of these devices include: increased length of time to observe outcomes, difficulties in finding validated meaures for use in studies, unknown long-term effects, lack of funding, and a low amount of patients simultaneously diagnosed with RP lacking other comorbid conditions. The ARGUS II did get FDA and CE mark approval so it was deemed safe and also effective. However, the company became more focused on a visual cortical implant. Future efforts are headed towards more biocompatible, safe, and efficacious devices.

目的:回顾不同的视网膜和视觉假体治疗色素性视网膜炎的现有证据,以及其他适应症的新植入物,包括干性年龄相关性黄斑变性。方法:PubMed、GoogleScholar、ScienceDirect和ClinicalTrials数据库是进行医学文献检索的主要资源。我们进行了广泛的检索,以确定截至2022年12月有关视网膜假体、临床试验、设备现状和潜在未来方向的全球进展的相关文章。结果:13个装置为电流,按刺激位置排序。其中6种正在进行临床试验。其中四种已停产,包括已获得FDA和CE标志批准的Alpha IMS、Alpha AMS、IRIS II和ARGUS II。未来的发展方向将在回顾中提出。结论:本综述提供了最新的视网膜假体装置,包括当前的和已停用的。虽然一些设备已经在动物和/或人类中实现了视觉感知,但阻碍这些设备商业化的主要问题包括:观察结果的时间延长,难以找到用于研究的有效措施,未知的长期影响,缺乏资金,以及同时诊断为RP的患者数量少,缺乏其他合共病。ARGUS II确实获得了FDA和CE的批准,因此它被认为是安全有效的。然而,该公司更专注于视觉皮质植入物。未来的努力将朝着更具生物相容性、安全性和有效性的设备迈进。
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引用次数: 0
Treating patients with geographic atrophy: are we there yet? 治疗地理萎缩患者:我们做到了吗?
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-20 DOI: 10.1186/s40942-023-00493-6
Bani Antonio-Aguirre, J Fernando Arevalo

Geographic atrophy (GA) is a progressive degenerative disease that significantly contributes to visual impairment in individuals aged 50 years and older. The development of GA is influenced by various modifiable and non-modifiable risk factors, including age, smoking, and specific genetic variants, particularly those related to the complement system regulators. Given the multifactorial and complex nature of GA, several treatment approaches have been explored, such as complement inhibition, gene therapy, and cell therapy. The recent approval by the Food and Drug Administration of pegcetacoplan, a complement C3 inhibitor, marks a significant breakthrough as the first approved treatment for GA. Furthermore, numerous interventions are currently in phase II or III trials, alongside this groundbreaking development. In light of these advancements, this review provides a comprehensive overview of GA, encompassing risk factors, prevalence, genetic associations, and imaging characteristics. Additionally, it delves into the current landscape of GA treatment, emphasizing the latest progress and future considerations. The goal of starting this discussion is to ultimately identify the most suitable candidates for each therapy, highlight the importance of tailoring treatments to individual cases, and continue monitoring the long-term implications of these emerging interventions.

地理萎缩(GA)是一种进行性退行性疾病,在50岁及以上的个体中显著导致视力损害。GA的发展受到各种可改变和不可改变的危险因素的影响,包括年龄、吸烟和特定的遗传变异,特别是与补体系统调节因子相关的遗传变异。鉴于GA的多因素和复杂性,已经探索了几种治疗方法,如补体抑制、基因治疗和细胞治疗。最近美国食品和药物管理局(fda)批准补体C3抑制剂pegcetacoplan,标志着GA首个获批治疗的重大突破。此外,在这一突破性进展的同时,许多干预措施目前正在进行II期或III期试验。鉴于这些进展,本文综述了GA的全面概述,包括危险因素、患病率、遗传关联和影像学特征。此外,它还深入研究了GA治疗的现状,强调了最新进展和未来的考虑。开始讨论的目的是最终确定每种治疗方法的最合适人选,强调针对个别病例量身定制治疗方法的重要性,并继续监测这些新兴干预措施的长期影响。
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引用次数: 0
"Application and accuracy of artificial intelligence-derived large language models in patients with age related macular degeneration". 人工智能衍生的大型语言模型在年龄相关性黄斑变性患者中的应用及准确性
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-18 DOI: 10.1186/s40942-023-00511-7
Lorenzo Ferro Desideri, Janice Roth, Martin Zinkernagel, Rodrigo Anguita

Introduction: Age-related macular degeneration (AMD) affects millions of people globally, leading to a surge in online research of putative diagnoses, causing potential misinformation and anxiety in patients and their parents. This study explores the efficacy of artificial intelligence-derived large language models (LLMs) like in addressing AMD patients' questions.

Methods: ChatGPT 3.5 (2023), Bing AI (2023), and Google Bard (2023) were adopted as LLMs. Patients' questions were subdivided in two question categories, (a) general medical advice and (b) pre- and post-intravitreal injection advice and classified as (1) accurate and sufficient (2) partially accurate but sufficient and (3) inaccurate and not sufficient. Non-parametric test has been done to compare the means between the 3 LLMs scores and also an analysis of variance and reliability tests were performed among the 3 groups.

Results: In category a) of questions, the average score was 1.20 (± 0.41) with ChatGPT 3.5, 1.60 (± 0.63) with Bing AI and 1.60 (± 0.73) with Google Bard, showing no significant differences among the 3 groups (p = 0.129). The average score in category b was 1.07 (± 0.27) with ChatGPT 3.5, 1.69 (± 0.63) with Bing AI and 1.38 (± 0.63) with Google Bard, showing a significant difference among the 3 groups (p = 0.0042). Reliability statistics showed Chronbach's α of 0.237 (range 0.448, 0.096-0.544).

Conclusion: ChatGPT 3.5 consistently offered the most accurate and satisfactory responses, particularly with technical queries. While LLMs displayed promise in providing precise information about AMD; however, further improvements are needed especially in more technical questions.

导言:年龄相关性黄斑变性(AMD)影响着全球数百万人,导致对假定诊断的在线研究激增,给患者及其父母带来潜在的错误信息和焦虑。本研究探讨了人工智能衍生的大型语言模型(LLMs)在解决AMD患者问题方面的功效。方法:采用ChatGPT 3.5(2023)、Bing AI(2023)、谷歌Bard(2023)作为LLMs。患者的问题被细分为两个问题类别,(a)一般医疗建议和(b)玻璃体内注射前后的建议,并分为(1)准确和充分(2)部分准确但充分和(3)不准确和不充分。进行了非参数检验以比较3个LLMs分数之间的平均值,并在3组之间进行了方差分析和信度检验。结果:在a类问题中,ChatGPT 3.5组平均得分为1.20(±0.41)分,Bing AI组平均得分为1.60(±0.63)分,b谷歌Bard组平均得分为1.60(±0.73)分,3组间差异无统计学意义(p = 0.129)。ChatGPT 3.5组平均得分为1.07(±0.27)分,Bing AI组平均得分为1.69(±0.63)分,b谷歌Bard组平均得分为1.38(±0.63)分,3组间差异有统计学意义(p = 0.0042)。信度统计结果显示,Chronbach’s α为0.237(范围0.448,0.096 ~ 0.544)。结论:ChatGPT 3.5始终提供最准确和令人满意的响应,特别是在技术查询方面。llm有望提供有关AMD的精确信息;但是,需要进一步改进,特别是在技术性较强的问题上。
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引用次数: 0
Unraveling the mysteries of macular telangiectasia 2: the intersection of philanthropy, multimodal imaging and molecular genetics. The 2022 founders lecture of the pan American vitreoretinal society. 解开黄斑毛细血管扩张的奥秘2:慈善事业,多模态成像和分子遗传学的交集。2022年泛美玻璃体视网膜学会创始人讲座。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-15 DOI: 10.1186/s40942-023-00505-5
Lihteh Wu

Purpose: Offer a personal perspective on the scientific advances on macular telangiectasia type 2 (MacTel2) since the launch of the MacTel Project in 2005.

Design: Literature review and personal perspective.

Methods: Critical review of the peer-reviewed literature and personal perspective.

Results: Generous financial support from the Lowy Medical Research Institute laid the foundations of the MacTel Project. MacTel Project investigators used state of the art multimodal retinal imaging and advanced modern biological methods to unravel many of the mysteries surrounding MacTel2. Major accomplishments includes elucidation of the pathogenic role that low serine levels, elevated 1-deoxysphingolipids and other mechanisms induce mitochondrial dysfunction which lead to Müller cell and photoreceptor degeneration; the use of objective measures of retinal structures such as the area of ellipsoid zone disruption as an outcome measure in clinical trials; the demonstration that the ciliary neurotrophic factor slows down retinal degeneration and the development of a new severity scale classification based on multimodal imaging findings.

Conclusions: MacTel2 is a predominantly metabolic disease characterized by defects in energy metabolism. Despite relatively good visual acuities, MacTel2 patients experience significant visual disability. The Mac Tel Project has been instrumental in advancing MacTel2 knowledge in the past two decades.

目的:介绍自2005年MacTel项目启动以来,黄斑毛细血管扩张2型(MacTel2)的科学进展。设计:文献综述和个人观点。方法:对同行评议文献和个人观点进行批判性回顾。结果:洛伊医学研究所慷慨的财政支持为MacTel项目奠定了基础。MacTel项目的研究人员使用了最先进的多模态视网膜成像技术和先进的现代生物学方法来解开围绕MacTel2的许多谜团。主要成果包括阐明了低丝氨酸水平、1-脱氧鞘脂升高和其他机制诱导线粒体功能障碍导致勒细胞和光感受器变性的致病作用;使用客观测量视网膜结构,如椭球区破坏面积作为临床试验的结果测量;睫状体神经营养因子减缓视网膜变性的证明和基于多模态影像学发现的新的严重程度分级的发展。结论:MacTel2是一种以能量代谢缺陷为特征的主要代谢性疾病。尽管视力相对较好,但MacTel2患者有明显的视力障碍。在过去的二十年里,MacTel项目在推进MacTel2知识方面发挥了重要作用。
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引用次数: 0
Correlations between subfoveal choroidal thickness, macular thickness, and visual outcome in neovascular age-related macular degeneration using swept source OCT: insights from intravitreal aflibercept treatment. 扫描源OCT在新生血管性年龄相关性黄斑变性中,中央凹下脉络膜厚度、黄斑厚度和视觉结果的相关性:来自玻璃体腔内阿布西普治疗的见解。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-15 DOI: 10.1186/s40942-023-00506-4
Daniel P Beraldo, Marcussi P Rezende, João G Alexander, Júlia Polido, Rubens Belfort, Thiago Cabral

Background: Age-related macular degeneration (AMD) is a leading cause of visual impairment among individuals aged 50 and above, often resulting in irreversible vision loss (1). Currently, antiangiogenic therapy is the primary treatment approach for neovascular AMD (2). The choroid has gained significant attention in recent years due to its involvement in various ocular pathologies (7). The objective of this study was to evaluate visual acuity and correlate pre-treatment variables, such as foveal thickness and choroidal thickness, with post-treatment outcomes.

Materials and methods: This study was designed as a prospective interventional study to investigate the changes in choroidal and macular thickness in patients with neovascular AMD who received intravitreal aflibercept injections. The study utilized medical records and employed Swept Source Optical Coherence Tomography (OCT-SS) for evaluation. The data was collected from patients treated in Presidente Prudente, Brazil, during a three-month load dose period.

Results: The best-corrected mean visual acuity significantly improved from 1.0 logarithm of the minimum resolution angle (logMAR) units to 0.55 logMAR after treatment with aflibercept (p < 0.001). Patients undergoing treatment exhibited a significant decrease in average macular thickness from 323 μm to 232 μm (p = 0.001), as well as a reduction in choroidal thickness from 206 μm to 172 μm (p = 0.031), while maintaining intraocular pressure within the normal range (p = 0.719) without significant variation. Statistically significant associations were found between the difference in pre- and post-treatment choroidal thickness and the pretreatment values of macular thickness (p = 0.005) and choroidal thickness (p = 0.013). There was also a statistically significant correlation between the difference in pre- and post-treatment macular thickness and the pretreatment macular thickness value (p < 0.001).

Conclusion: In this study, aflibercept exhibited remarkable effectiveness in reducing macular and choroidal thickness, as evaluated using OCT-SS, and significantly improved visual acuity in patients with neovascular AMD. The assessment of both choroidal and macular changes, as well as their correlations, can provide valuable insights for clinicians, enabling them to make well-informed therapeutic decisions and effectively monitor treatment outcomes. Notably, this study contributes to the existing body of literature as the first to establish a correlation between pretreatment foveal thickness, variation in choroidal thickness, and post-treatment choroidal thickness.

背景:年龄相关性黄斑变性(AMD)是50岁及以上人群视力损害的主要原因,通常导致不可逆的视力丧失(1)。目前,抗血管生成治疗是新生血管性AMD的主要治疗方法(2)。脉络膜近年来因其涉及各种眼部病变而受到广泛关注(7)。本研究的目的是评估视力和相关的治疗前变量。如中央凹厚度和脉络膜厚度,与治疗后的结果。材料和方法:本研究是一项前瞻性介入研究,旨在探讨新生血管性AMD患者接受玻璃体腔内注射阿布西普后脉络膜和黄斑厚度的变化。本研究利用医疗记录和扫描源光学相干断层扫描(OCT-SS)进行评估。数据收集自在巴西总统普吕登特(Presidente Prudente)接受三个月负荷剂量治疗的患者。结果:阿非利西普治疗后最佳矫正平均视力从1.0对数最小分辨角(logMAR)单位显著提高到0.55对数角(logMAR)单位(p)。结论:在本研究中,使用OCT-SS评估阿非利西普对减少黄斑和脉膜厚度有显著效果,并显著改善新生血管性AMD患者的视力。脉络膜和黄斑变化的评估及其相关性可以为临床医生提供有价值的见解,使他们能够做出明智的治疗决策并有效地监测治疗结果。值得注意的是,本研究首次建立了预处理中央凹厚度、脉络膜厚度变化和处理后脉络膜厚度之间的相关性,为现有文献做出了贡献。
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引用次数: 0
Anatomical and functional results after vitrectomy with conventional ILM peeling versus inverted ILM flap technique in large full-thickness macular holes. 玻璃体切除术后常规ILM剥离术与倒置ILM瓣技术在大全层黄斑孔中的解剖和功能对比。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-14 DOI: 10.1186/s40942-023-00509-1
Adrianna U Dera, Doerte Stoll, Verena Schoeneberger, Marcus Walckling, Claudia Brockmann, Thomas A Fuchsluger, Friederike Schaub

Background: Aim of the study was to compare success rate and functional outcome following pars plana vitrectomy (PPV) with conventional internal limiting membrane (ILM) peeling versus ILM flap technique for full-thickness idiopathic macular holes (FTMH).

Methods: Retrospective analysis of consecutive eyes with FTMH having undergone vitrectomy with sulfur hexafluoride (SF6) endotamponade 25% at the University Medical Center Rostock, Germany (2009-2020). Eyes were divided according to applied surgical technique (ILM peeling [group P] versus ILM flap [group F]). Inclusion criteria were macular hole base diameters (MH-BD) ≥ 400 μm plus axial length ≤ 26.0 mm. Each group was divided into two subgroups based on macular hole minimum linear diameter (MH-MLD): ≤ 400 μm and > 400 μm. Exclusion criteria were FTMH with MH-BD < 400 μm, trauma, myopia with axial length > 26.0 mm or macular schisis. Demographic, functional, and anatomical data were obtained pre- and postoperatively. Preoperative MH-BD and MH-MLD were measured using optical coherence tomography (OCT; Spectralis®, Heidelberg Engineering GmbH, Heidelberg, Germany). Main outcome parameter were: primary closure rate, best-corrected visual acuity (BCVA), and re-surgery rate.

Results: Overall 117 eyes of 117 patients with FTMH could be included, thereof 52 eyes underwent conventional ILM peeling (group P) and 65 additional ILM flap (group F) technique. Macular hole closure was achieved in 31 eyes (59.6%) in group P and in 59 eyes (90.8%) in group F (p < 0.001). Secondary PPV was required in 21 eyes (40.4%) in group P and in 6 eyes (9.2%) in group F. Postoperative BCVA at first follow-up in eyes with surgical closure showed no significant difference for both groups (MH-MLD ≤ 400 μm: p = 0.740); MH-MLD > 400 μm: p = 0.241).

Conclusion: Anatomical results and surgical closure rate following ILM flap technique seems to be superior to conventional ILM peeling for treatment of FTMH.

背景:研究的目的是比较常规内限制膜(ILM)剥离与ILM皮瓣技术治疗全层特发性黄斑孔(FTMH)的成功率和功能结果。方法:回顾性分析2009-2020年在德国罗斯托克大学医学中心接受25%六氟化硫(SF6)内填塞玻璃体切除术的连续眼FTMH患者。按应用手术技术分眼(ILM剥离[P组]和ILM皮瓣[F组])。纳入标准为黄斑孔底直径(MH-BD)≥400 μm +轴向长度≤26.0 mm。各组根据黄斑孔最小线性直径(MH-MLD)分为≤400 μm和> 400 μm两组。排除标准为伴MH-BD 26.0 mm或黄斑裂的FTMH。术前和术后获得人口学、功能和解剖学数据。术前采用光学相干断层扫描(OCT)测量MH-BD和MH-MLD;Spectralis®,海德堡工程有限公司,海德堡,德国)。主要结局参数为:初次闭合率、最佳矫正视力(BCVA)、再手术率。结果117例FTMH患者共117眼,其中常规ILM剥离52眼(P组),外加ILM瓣技术65眼(F组)。P组31眼(59.6%)、F组59眼(90.8%)完成黄斑孔闭合(P 400 μm: P = 0.241)。结论:ILM皮瓣技术治疗FTMH的解剖效果和手术闭合率优于传统的ILM剥离。
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引用次数: 0
Image Calibration in choroidal vascularity index measurement. 脉络膜血管指数测量中的图像校准。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-10 DOI: 10.1186/s40942-023-00508-2
Kiana Hassanpour, Hamid Ahmadieh
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引用次数: 0
Image calibration in choroidal vascularity index measurement. 脉络膜血管指数测量中的图像校准。
IF 2.3 Q2 OPHTHALMOLOGY Pub Date : 2023-11-10 DOI: 10.1186/s40942-023-00503-7
Mehrdad Motamed Shariati, Nasser Shoeibi

Choroid is a tissue with a very high blood flow which is a metabolic supporter of the retina. Recently, the study of choroidal blood flow in ocular and systemic disorders is a hot topic in scientific research. With the advent of enhanced depth imaging OCT (EDI-OCT), it is possible to measure the entire choroidal thickness. The choroidal vascularity index (CVI) is a relatively new index in studying choroidal hemodynamics. However, the CVI measurement needs image processing. Image calibration is a necessary step before any image processing with software such as ImageJ.

脉络膜是一种血流量非常高的组织,是视网膜的代谢支持物。近年来,脉络膜血流在眼部和全身疾病中的研究是科学研究的热点。随着增强型深度成像OCT(EDI-OCT)的出现,可以测量整个脉络膜厚度。脉络膜血管指数(CVI)是研究脉络膜血流动力学的一个相对较新的指标。然而,CVI测量需要图像处理。在使用诸如ImageJ之类的软件进行任何图像处理之前,图像校准是必要的步骤。
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引用次数: 0
Pharmaceutical compounding and storage of faricimab in a syringe for intravitreal injection do not impair stability and bi-specific binding properties. 玻璃体内注射用注射器中法利昔单抗的药物配制和储存不会损害稳定性和双特异性结合特性。
IF 1.9 Q2 OPHTHALMOLOGY Pub Date : 2023-11-07 DOI: 10.1186/s40942-023-00507-3
Øystein Kalsnes Jørstad, Stian Foss, Torleif Tollefsrud Gjølberg, Simone Mester, Mari Nyquist-Andersen, Magne Sand Sivertsen, Dag Fossum, Espen Gleditsch, Morten Carstens Moe, Jan Terje Andersen

Background: Intravitreal injection (IVI) of antibody biologics is a key treatment approach in ophthalmology. Pharmaceutical compounding and storage of prefilled syringes for IVI must take place without impairing the structure and function of the biologics. This study investigated the effect of withdrawing and storing the therapeutic antibody faricimab (Vabysmo, Roche, Basel, Switzerland) in the Zero Residual silicone oil-free, 0.2-mL syringe (SJJ Solutions, The Hague, the Netherlands).

Methods: To assess the effect of syringe withdrawal on faricimab, we compared samples from syringes prepared at day 0 with samples taken directly from faricimab vials. To assess the effect of syringe storage on faricimab, we kept prefilled syringes in the dark at 4 oC for 7, 14, or 37 days and compared samples from these syringes with day 0. We measured protein concentration (with spectrophotometry), stability and integrity (with sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), size-exclusion chromatography (SEC), and melting temperature (Tm)), as well as binding of faricimab to its cognate antigens: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) (with enzyme-linked immunosorbent assay (ELISA)).

Results: Faricimab migrated in line with its expected molecular mass under both reducing and non-reducing conditions for all time points when analyzed with SDS-PAGE, without any sign of degradation products or aggregation. The SEC elution profiles were identical for all time points. There were slight variations in Tm for different time points compared to day 0 but without consistent relationship with storage time. ELISA did not detect differences in VEGF-A or Ang-2 binding between time points, and faricimab did not bind the neonatal Fc receptor.

Conclusions: Withdrawal and storage of faricimab in syringes for up to day 37 did not impair the structure and bi-specific binding properties of the therapeutic antibody.

背景:抗体生物制品的玻璃体内注射(IVI)是眼科的一种关键治疗方法。IVI预充注射器的药物配制和储存必须在不损害生物制品结构和功能的情况下进行。本研究调查了在零残留无硅油0.2毫升注射器(SJJ Solutions,the Hague,the Netherlands)中提取和储存治疗性抗体faricimab(Vabysmo,Roche,Basel,Switzerland)的效果,我们比较了在第0天制备的注射器样品和直接从法利昔单抗小瓶中提取的样品。为了评估注射器储存对法利昔单抗的影响,我们将预充注射器在4℃的黑暗中放置7、14或37天,并将这些注射器的样品与第0天进行比较。我们测量了蛋白质浓度(用分光光度法)、稳定性和完整性(用十二烷基硫酸钠-聚丙烯酰胺凝胶电泳(SDS-PAGE)、尺寸排阻色谱(SEC)和熔融温度(Tm)),以及法利昔单抗与其同源抗原:血管内皮生长因子A(VEGF-A)和血管生成素-2(Ang-2)的结合(酶联免疫吸附试验(ELISA)),没有任何降解产物或聚集的迹象。SEC洗脱图谱在所有时间点都是相同的。与第0天相比,不同时间点的Tm略有变化,但与储存时间没有一致的关系。ELISA没有检测到不同时间点之间VEGF-A或Ang-2结合的差异,法利昔单抗也没有结合新生儿Fc受体。结论:法利昔单抗在注射器中提取和储存至第37天不会损害治疗性抗体的结构和双特异性结合特性。
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引用次数: 0
期刊
International Journal of Retina and Vitreous
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