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, Susanna
name: Asgari, Nasrin
name: Bennett, Jeffrey
name: Bialer, Omer
name: Blanco, Yolanda
name: Bosello, Francesca
name: Camos-Carreras, Anna
name: Carnero Contentti, Edgar
name: Carta, Sara
name: Chen, John
name: Chien, Claudia
name: Chomba, Mashina
name: Dale, Russell C.
name: Dalmau, Josep
name: Feldmann, Kristina
name: Flanagan, Eoin P.
name: Froment Tilikete, Caroline
name: Garcia-Alfonso, Carolina
name: Havla, Joachim
name: Hellmann, Mark
name: Kim, Ho Jin
name: Klyscz, Philipp
name: Konietschke, Frank
name: La Morgia, Chiara
name: Lana-Peixoto, Marco
name: Leite, Maria Isabel
name: Levin, Netta
name: Levy, Michael
name: Llufriu, Sara
name: Lopez, Pablo
name: Lotan, Itay
name: Lugaresi, Alessandra
name: Marignier, Romain
name: Mariotto, Sara
name: Mollan, Susan P.
name: Ocampo, Cassandra
name: Cosima Oertel, Frederike
name: Olszewska, Maja
name: Palace, Jacqueline
name: Pandit, Lekha
name: Peralta Uribe, José Luis
name: Pittock, Sean
name: Ramanathan, Sudarshini
name: Rattanathamsakul, Natthapon
name: Saiz, Albert
name: Samadzadeh, Sara
name: Sanchez-Dalmau, Bernardo
name: Saylor, Deanna
name: Scheel, Michael
name: Schmitz-Hübsch, Tanja
name: Shifa, Jemal
name: Siritho, Sasitorn
name: Sperber, Pia S.
name: Subramanian, Prem S.
name: Tiosano, Alon
name: Vaknin-Dembinsky, Adi
name: Mejia Vergara, Alvaro Jose
name: Wilf-Yarkoni, Adi
name: Zarco, Luis Alfonso
name: Zimmermann, Hanna G.
name: Paul, Friedemann
name: Stiebel-Kalish, Hadas
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2023
Subjects: subject: Aquaporin-4-IgG (AQP4-IgG)
subject: clinically isolated syndrome (CIS)
subject: MOG-IgG associated disorders (MOGAD)
subject: multiple sclerosis (MS)
subject: neuromyelitis optica spectrum disorders (NMOSD)
subject: optic neuritis (ON)
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: 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.