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The Acute Optic Neuritis Network (ACON): study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis

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Item Type:Article
Title:The Acute Optic Neuritis Network (ACON): study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis
Creators Name:Asseyer, S. and Asgari, N. and Bennett, J. and Bialer, O. and Blanco, Y. and Bosello, F. and Camos-Carreras, A. and Carnero Contentti, E. and Carta, S. and Chen, J. and Chien, C. and Chomba, M. and Dale, R.C. and Dalmau, J. and Feldmann, K. and Flanagan, E.P. and Froment Tilikete, C. and Garcia-Alfonso, C. and Havla, J. and Hellmann, M. and Kim, H.J. and Klyscz, P. and Konietschke, F. and La Morgia, C. and Lana-Peixoto, M. and Leite, M.I. and Levin, N. and Levy, M. and Llufriu, S. and Lopez, P. and Lotan, I. and Lugaresi, A. and Marignier, R. and Mariotto, S. and Mollan, S.P. and Ocampo, C. and Oertel, F.C. and Olszewska, M. and Palace, J. and Pandit, L. and Peralta Uribe, J.L. and Pittock, S. and Ramanathan, S. and Rattanathamsakul, N. and Saiz, A. and Samadzadeh, S. and Sanchez-Dalmau, B. and Saylor, D. and Scheel, M. and Schmitz-Hübsch, T. and Shifa, J. and Siritho, S. and Sperber, P.S. and Subramanian, P.S. and Tiosano, A. and Vaknin-Dembinsky, A. and Mejia Vergara, A.J. and Wilf-Yarkoni, A. and Zarco, L.A. and Zimmermann, H.G. and Paul, F. and Stiebel-Kalish, H.
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.
Keywords:Aquaporin-4-IgG (AQP4-IgG), Clinically Isolated Syndrome (CIS), MOG-IgG Associated Disorders (MOGAD), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Optic Neuritis (ON)
Source:Frontiers in Neurology
Publisher:Frontiers Media SA
Page Range:1102353
Date:24 February 2023
Official Publication:https://doi.org/10.3389/fneur.2023.1102353
PubMed:View item in PubMed

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