Oral lamivudine in diabetic macular edema: A randomized, double-blind, placebo-controlled clinical trial.

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Med Pub Date : 2025-05-23 DOI:10.1016/j.medj.2025.100747
Felipe Pereira, Joseph Magagnoli, Meenakshi Ambati, Talita Fernandes de Oliveira, Juliana Angélica Estevão de Oliveira, Vinicius Oliveira Pesquero, Lucas Zago Ribeiro, Dante Akira Kondo Kuroiwa, Fernando Korn Malerbi, Sergio Atala Dib, Nilva Bueno Moraes, Michel Eid Farah, Eduardo Buchele Rodrigues, Jayakrishna Ambati
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引用次数: 0

Abstract

Background: Diabetic macular edema (DME) affects millions worldwide. Intraocular injections of expensive anti-vascular endothelial growth factor (VEGF) inhibitors associated with complications are standard therapy. Lamivudine, an inexpensive oral drug, inhibits inflammasome activation, which is implicated in DME. This randomized, double-blind, placebo-controlled trial compared oral lamivudine to placebo for improving visual acuity in center-involved DME (CI-DME).

Methods: Twenty-four adults enrolled between February 2022 and September 2023 with 1 or 2 eyes with CI-DME and a best-corrected visual acuity (BCVA) of less than 69 letters (Brazilian Registry of Clinical Trials RBR-87b6r5s) were randomized to lamivudine (150 mg twice daily; 10 participants; 16 eyes) or placebo (14 participants; 21 eyes) for 8 weeks. Participants were assigned intravitreous bevacizumab (1.25 mg) at week 4. Co-primary outcomes were mean changes in BCVA from baseline to weeks 4 and 8. Comparisons to anti-VEGF drugs used synthetic controls from DRCR.net Protocol T. Secondary outcomes included retinal thickness and adverse events.

Findings: At 4 weeks, BCVA improved 9.8 letters with lamivudine and decreased 1.8 letters with placebo (p < 0.001). At 8 weeks, BCVA improved 16.9 letters with lamivudine and bevacizumab and 5.3 letters with placebo and bevacizumab (p < 0.001). Lamivudine was associated with greater BCVA improvement than bevacizumab or ranibizumab (p < 0.05) and was not different from aflibercept (p = 0.5). There was no significant difference in retinal thickness or adverse events between groups.

Conclusions: Lamivudine, an oral inflammasome inhibitor, significantly improved vision in patients with CI-DME.

Funding: This work was supported by Universidade Federal de São Paulo, Latinofarma, UVA SIF, and NIH.

口服拉米夫定治疗糖尿病黄斑水肿:一项随机、双盲、安慰剂对照的临床试验。
背景:糖尿病性黄斑水肿(DME)影响着全世界数百万人。眼内注射昂贵的与并发症相关的抗血管内皮生长因子(VEGF)抑制剂是标准的治疗方法。拉米夫定是一种廉价的口服药物,可抑制与二甲醚有关的炎性体活化。这项随机、双盲、安慰剂对照试验比较了口服拉米夫定和安慰剂对改善中心受累DME (CI-DME)患者视力的作用。方法:在2022年2月至2023年9月期间招募的24名1眼或2眼CI-DME患者,最佳矫正视力(BCVA)小于69字母(巴西临床试验登记处RBR-87b6r5s)随机分配拉米夫定(150 mg,每日两次;10个参与者;16只眼睛)或安慰剂(14名参与者;21只眼睛),持续8周。在第4周,参与者被分配静脉注射贝伐单抗(1.25 mg)。共同主要结局是BCVA从基线到第4周和第8周的平均变化。与DRCR.net方案t中合成对照抗vegf药物的比较,次要结局包括视网膜厚度和不良事件。结果:4周时,拉米夫定组BCVA改善了9.8个字母,安慰剂组降低了1.8个字母(p < 0.001)。8周时,拉米夫定和贝伐单抗组的BCVA改善了16.9个字母,安慰剂和贝伐单抗组的BCVA改善了5.3个字母(p < 0.001)。拉米夫定与贝伐单抗或雷尼单抗的BCVA改善相关(p < 0.05),与阿非利西普无差异(p = 0.5)。两组之间视网膜厚度和不良事件无显著差异。结论:口服炎性体抑制剂拉米夫定可显著改善CI-DME患者的视力。资金:这项工作得到了圣保罗联邦大学、拉丁农业大学、UVA SIF和NIH的支持。
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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来源期刊
Med
Med MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
17.70
自引率
0.60%
发文量
102
期刊介绍: Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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