Asseyer Susanna, Asgari Nasrin, Bennett Jeffrey, Bialer Omer, Blanco Yolanda, Bosello Francesca, Camos-Carreras Anna, Carnero Contentti Edgar, Carta Sara, Chen John, Chien Claudia, Chomba Mashina, Dale Russell C, Dalmau Josep, Feldmann Kristina, Flanagan Eoin P, Froment Tilikete Caroline, Garcia-Alfonso Carolina, Havla Joachim, Hellmann Mark, Kim Ho Jin, Klyscz Philipp, Konietschke Frank, La Morgia Chiara, Lana-Peixoto Marco, Leite Maria Isabel, Levin Netta, Levy Michael, Llufriu Sara, Lopez Pablo, Lotan Itay, Lugaresi Alessandra, Marignier Romain, Mariotto Sara, Mollan Susan P, Ocampo Cassandra, Cosima Oertel Frederike, Olszewska Maja, Palace Jacqueline, Pandit Lekha, Peralta Uribe José Luis, Pittock Sean, Ramanathan Sudarshini, Rattanathamsakul Natthapon, Saiz Albert, Samadzadeh Sara, Sanchez-Dalmau Bernardo, Saylor Deanna, Scheel Michael, Schmitz-Hübsch Tanja, Shifa Jemal, Siritho Sasitorn, Sperber Pia S, Subramanian Prem S, Tiosano Alon, Vaknin-Dembinsky Adi, Mejia Vergara Alvaro Jose, Wilf-Yarkoni Adi, Zarco Luis Alfonso, Zimmermann Hanna G, Paul Friedemann, Stiebel-Kalish Hadas
Experimental and Clinical Research Center, A Cooperation Between the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité Universitätsmedizin Berlin, Berlin, Germany.
Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Experimental and Clinical Research Center, Berlin, Germany.
Front Neurol. 2023 Feb 24;14:1102353. doi: 10.3389/fneur.2023.1102353. eCollection 2023.
Optic neuritis (ON) often occurs at the presentation of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD). The recommended treatment of high-dose corticosteroids for ON is based on a North American study population, which did not address treatment timing or antibody serostatus. The Acute Optic Neuritis Network (ACON) presents a global, prospective, observational study protocol primarily designed to investigate the effect of time to high-dose corticosteroid treatment on 6-month visual outcomes in ON. Patients presenting within 30 days of the inaugural ON will be enrolled. For the primary analysis, patients will subsequently be assigned into the MS-ON group, the aquapotin-4-IgG positive ON (AQP4-IgG+ON) group or the MOG-IgG positive ON (MOG-IgG+ON) group and then further sub-stratified according to the number of days from the onset of visual loss to high-dose corticosteroids (). The primary outcome measure will be high-contrast best-corrected visual acuity (HC-BCVA) at 6 months. In addition, multimodal data will be collected in subjects with any ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON, and seronegative non-MS-ON), excluding infectious and granulomatous ON. Secondary outcomes include low-contrast best-corrected visual acuity (LC-BCVA), optical coherence tomography (OCT), magnetic resonance imaging (MRI) measurements, serum and cerebrospinal fluid (CSF) biomarkers (AQP4-IgG and MOG-IgG levels, neurofilament, and glial fibrillary protein), and patient reported outcome measures (headache, visual function in daily routine, depression, and quality of life questionnaires) at presentation at 6-month and 12-month follow-up visits. Data will be collected from 28 academic hospitals from Africa, Asia, the Middle East, Europe, North America, South America, and Australia. Planned recruitment consists of 100 MS-ON, 50 AQP4-IgG+ON, and 50 MOG-IgG+ON. This prospective, multimodal data collection will assess the potential value of early high-dose corticosteroid treatment, investigate the interrelations between functional impairments and structural changes, and evaluate the diagnostic yield of laboratory biomarkers. This analysis has the ability to substantially improve treatment strategies and the accuracy of diagnostic stratification in acute demyelinating ON.
ClinicalTrials.gov, identifier: NCT05605951.
视神经炎（ON）常出现在多发性硬化症（MS）、视神经脊髓炎谱系障碍（NMOSD）和髓鞘少突胶质细胞糖蛋白（MOG）抗体相关疾病（MOGAD）的发病过程中。针对ON的高剂量皮质类固醇推荐治疗方案是基于北美研究人群制定的，该方案未涉及治疗时机或抗体血清状态。急性视神经炎网络（ACON）开展了一项全球前瞻性观察性研究方案，主要旨在研究高剂量皮质类固醇治疗时间对ON患者6个月视觉预后的影响。发病后30天内就诊的患者将被纳入研究。在主要分析中，患者随后将被分为MS-ON组、水通道蛋白4-IgG阳性ON（AQP4-IgG+ON）组或MOG-IgG阳性ON（MOG-IgG+ON）组，然后根据从视力丧失发作到接受高剂量皮质类固醇治疗的天数进一步分层。主要结局指标将是6个月时的高对比度最佳矫正视力（HC-BCVA）。此外，将收集所有ON患者（临床孤立综合征相关性ON、MS-ON、AQP4-IgG+ON或MOG-IgG+ON以及血清阴性非MS-ON）的多模态数据，排除感染性和肉芽肿性ON。次要结局包括6个月和12个月随访就诊时的低对比度最佳矫正视力（LC-BCVA）、光学相干断层扫描（OCT）、磁共振成像（MRI）测量、血清和脑脊液（CSF）生物标志物（AQP4-IgG和MOG-IgG水平、神经丝和胶质纤维酸性蛋白）以及患者报告的结局指标（头痛情况、日常生活中的视觉功能、抑郁情况以及生活质量问卷）。数据将从非洲、亚洲、中东、欧洲、北美、南美和澳大利亚的28家学术医院收集。计划招募100例MS-ON患者、50例AQP4-IgG+ON患者和50例MOG-IgG+ON患者。这项前瞻性多模态数据收集将评估早期高剂量皮质类固醇治疗的潜在价值，研究功能障碍与结构变化之间的相互关系，并评估实验室生物标志物的诊断价值。该分析有能力大幅改善急性脱髓鞘性ON的治疗策略和诊断分层的准确性。
ClinicalTrials.gov，标识符：NCT05605951。
