The Acute Optic Neuritis Network (ACON): study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis
Author
Asseyer, SusannaAsgari, 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
Publication date
2023-02-24
Metadata
Show full item recordAbstract
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.Citation
Asseyer S, Asgari N, Bennett J, Bialer O, Blanco Y, Bosello F, Camos-Carreras A, Carnero Contentti E, Carta S, Chen J, Chien C, Chomba M, Dale RC, Dalmau J, Feldmann K, Flanagan EP, Froment Tilikete C, Garcia-Alfonso C, Havla J, Hellmann M, Kim HJ, Klyscz P, Konietschke F, La Morgia C, Lana-Peixoto M, Leite MI, Levin N, Levy M, Llufriu S, Lopez P, Lotan I, Lugaresi A, Marignier R, Mariotto S, Mollan SP, Ocampo C, Cosima Oertel F, Olszewska M, Palace J, Pandit L, Peralta Uribe JL, Pittock S, Ramanathan S, Rattanathamsakul N, Saiz A, Samadzadeh S, Sanchez-Dalmau B, Saylor D, Scheel M, Schmitz-Hübsch T, Shifa J, Siritho S, Sperber PS, Subramanian PS, Tiosano A, Vaknin-Dembinsky A, Mejia Vergara AJ, Wilf-Yarkoni A, Zarco LA, Zimmermann HG, Paul F, Stiebel-Kalish H. The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis. Front Neurol. 2023 Feb 24;14:1102353. doi: 10.3389/fneur.2023.1102353Type
ArticleAdditional Links
http://www.frontiersin.org/neurologyPMID
36908609Journal
Frontiers in NeurologyPublisher
Frontiers Mediaae974a485f413a2113503eed53cd6c53
10.3389/fneur.2023.1102353