利用 PROOF 研究的真实世界数据预测抗血管内皮生长因子治疗新生血管性老年黄斑变性后的疾病活动。

IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Ophthalmology and Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-05 DOI:10.1007/s40123-024-01021-x
Min Sagong, Jae Hui Kim, Se Joon Woo, Yu Cheol Kim, Heeyoon Cho, Young Hoon Lee, Iksoo Byon, Young Joon Jo, Hee Seung Chin, Jeonghee Kim, Jae Eun Chae, Se Woong Kang
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引用次数: 0

摘要

简介本研究旨在调查在真实世界条件下,抗血管内皮生长因子(anti-VEGF)治疗新生血管性年龄相关性黄斑变性(nAMD)患者持续性疾病活动的预测因素及其长期影响:对PROOF研究进行了回顾性数据分析,该研究是在韩国各地对nAMD患者进行的多中心真实世界回顾性病历审查,包括2017年1月至2019年3月期间首次接受抗血管内皮生长因子(雷尼珠单抗、贝伐珠单抗或阿弗利贝赛普)治疗的未接受治疗的nAMD患者。所有600名患者(队列1)的随访时间至少为12个月,其中453名患者(队列2)的随访时间为自基线起24个月:抗 VEGF 治疗后第 12 个月,58.10%(95% 置信区间 [CI]:54.09, 62.12)的患者仍有持续视网膜积液;第 24 个月,66.02% 的患者仍有持续视网膜积液。在第 12 个月和第 24 个月,预测持续性疾病活动的因素是纤维血管性色素上皮脱离(PED)(P = 0.0494)和负荷阶段后第 3 个月的视网膜积液(P = 0.0082)。贝伐珠单抗组、阿弗利百普组和雷尼珠单抗组在12个月时视力的平均变化分别为+ 6.2、+ 10.1和+ 13.3个字母,中央子场厚度的平均变化分别为- 79.1微米、- 96.3微米和- 134.4微米:负荷期后出现视网膜积液和纤维血管性PED是抗VEGF治疗至少1年后疾病活动持续存在的预测因素。
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Predictors of Disease Activity After Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration Using Real-World Data from the PROOF Study.

Introduction: The aim of this study was to investigate the predictive factors for persistent disease activity following anti-vascular endothelial growth factors (anti-VEGF) and their long-term effects in patients to be treated for neovascular age-related macular degeneration (nAMD) under real-world conditions.

Methods: Retrospective data analysis of the PROOF study, a multi-center real-world retrospective chart review conducted across Korea in patients with nAMD included treatment-naive patients with nAMD who received first anti-VEGF (ranibizumab, bevacizumab, or aflibercept) between January 2017 and March 2019 was performed. All 600 patients (cohort 1) had a minimum follow-up of 12 months of which 453 patients (cohort 2) were followed-up for 24 months from baseline.

Results: At month 12 after anti-VEGF therapy, 58.10% (95% confidence interval [CI]: 54.09, 62.12) of patients and at month 24, 66.02% of patients continued to have persistent retinal fluid. At both months 12 and 24, predictive factors for persistent disease activity were fibrovascular pigment epithelial detachments (PED) (P = 0.0494) and retinal fluid at month 3 after loading phase (P = 0.0082). The mean changes in visual acuity were + 6.2, + 10.1, and + 13.3 letters and in the central subfield thickness were - 79.1 µm, - 96.3 µm, and - 134.4 µm at 12 months from baseline, in the bevacizumab, aflibercept, and ranibizumab groups, respectively.

Conclusions: The presence of retinal fluid after loading phase and fibrovascular PED were predictors of persistent disease activity after at least 1 year of anti-VEGF treatment.

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来源期刊
Ophthalmology and Therapy
Ophthalmology and Therapy OPHTHALMOLOGY-
CiteScore
4.20
自引率
3.00%
发文量
157
审稿时长
6 weeks
期刊介绍: Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. 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The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. 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At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website. Please follow the link for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Ophthalmology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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