The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis
Issued Date
2023-01-01
Resource Type
eISSN
16642295
Scopus ID
2-s2.0-85150165727
Journal Title
Frontiers in Neurology
Volume
14
Rights Holder(s)
SCOPUS
Bibliographic Citation
Frontiers in Neurology Vol.14 (2023)
Suggested Citation
Asseyer S. The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis. Frontiers in Neurology Vol.14 (2023). doi:10.3389/fneur.2023.1102353 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/82561
Title
The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis
Author(s)
Author's Affiliation
Siriraj Hospital
Oxford University Hospitals NHS Foundation Trust
Centre de Recherche en Neurosciences de Lyon
Deutsches Zentrum für Herz-Kreislauf-Forschung e. V.
Istituto delle Scienze Neurologiche di Bologna
University Teaching Hospital Lusaka
K.S. Hegde Medical Academy
National Cancer Center, Gyeonggi
Pontificia Universidad Javeriana
Università degli Studi di Verona
Hospital Clinic Barcelona
Universidade Federal de Minas Gerais
Massachusetts General Hospital
Concord Repatriation General Hospital
University of Colorado Anschutz Medical Campus
Alma Mater Studiorum Università di Bologna
The Children's Hospital at Westmead
Charité – Universitätsmedizin Berlin
The University of Sydney
Max Delbruck Center for Molecular Medicine
Rabin Medical Center Israel
University of Botswana
Bumrungrad International Hospital
University of Birmingham
Syddansk Universitet
Università degli Studi di Bologna, Facoltà di Medicina e Chirurgia
Slagelse Sygehus
Queen Elizabeth Hospital Birmingham
Hebrew University of Jerusalem
Hospital Aleman
University of Pennsylvania
Tel Aviv University
Mayo Clinic
Universitat de Barcelona
Johns Hopkins School of Medicine
Klinikum der Universität München
Fundación Universitaria Sanitas
Kids Cancer Centre
Einstein Center Digital Future
Oxford University Hospitals NHS Foundation Trust
Centre de Recherche en Neurosciences de Lyon
Deutsches Zentrum für Herz-Kreislauf-Forschung e. V.
Istituto delle Scienze Neurologiche di Bologna
University Teaching Hospital Lusaka
K.S. Hegde Medical Academy
National Cancer Center, Gyeonggi
Pontificia Universidad Javeriana
Università degli Studi di Verona
Hospital Clinic Barcelona
Universidade Federal de Minas Gerais
Massachusetts General Hospital
Concord Repatriation General Hospital
University of Colorado Anschutz Medical Campus
Alma Mater Studiorum Università di Bologna
The Children's Hospital at Westmead
Charité – Universitätsmedizin Berlin
The University of Sydney
Max Delbruck Center for Molecular Medicine
Rabin Medical Center Israel
University of Botswana
Bumrungrad International Hospital
University of Birmingham
Syddansk Universitet
Università degli Studi di Bologna, Facoltà di Medicina e Chirurgia
Slagelse Sygehus
Queen Elizabeth Hospital Birmingham
Hebrew University of Jerusalem
Hospital Aleman
University of Pennsylvania
Tel Aviv University
Mayo Clinic
Universitat de Barcelona
Johns Hopkins School of Medicine
Klinikum der Universität München
Fundación Universitaria Sanitas
Kids Cancer Centre
Einstein Center Digital Future
Other Contributor(s)
Abstract
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 (days-to-Rx). 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. Trial registration: ClinicalTrials.gov, identifier: NCT05605951.
