TY - JOUR
T1 - The Acute Optic Neuritis Network (ACON)
T2 - Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis
AU - Asseyer, Susanna
AU - Asgari, Nasrin
AU - Bennett, Jeffrey
AU - Bialer, Omer
AU - Blanco, Yolanda
AU - Bosello, Francesca
AU - Camos-Carreras, Anna
AU - Carnero Contentti, Edgar
AU - Carta, Sara
AU - Chen, John
AU - Chien, Claudia
AU - Chomba, Mashina
AU - Dale, Russell C.
AU - Dalmau, Josep
AU - Feldmann, Kristina
AU - Flanagan, Eoin P.
AU - Froment Tilikete, Caroline
AU - Garcia-Alfonso, Carolina
AU - Havla, Joachim
AU - Hellmann, Mark
AU - Kim, Ho Jin
AU - Klyscz, Philipp
AU - Konietschke, Frank
AU - La Morgia, Chiara
AU - Lana-Peixoto, Marco
AU - Leite, Maria Isabel
AU - Levin, Netta
AU - Levy, Michael
AU - Llufriu, Sara
AU - Lopez, Pablo
AU - Lotan, Itay
AU - Lugaresi, Alessandra
AU - Marignier, Romain
AU - Mariotto, Sara
AU - Mollan, Susan P.
AU - Ocampo, Cassandra
AU - Cosima Oertel, Frederike
AU - Olszewska, Maja
AU - Palace, Jacqueline
AU - Pandit, Lekha
AU - Peralta Uribe, José Luis
AU - Pittock, Sean
AU - Ramanathan, Sudarshini
AU - Rattanathamsakul, Natthapon
AU - Saiz, Albert
AU - Samadzadeh, Sara
AU - Sanchez-Dalmau, Bernardo
AU - Saylor, Deanna
AU - Scheel, Michael
AU - Schmitz-Hübsch, Tanja
AU - Shifa, Jemal
AU - Siritho, Sasitorn
AU - Sperber, Pia S.
AU - Subramanian, Prem S.
AU - Tiosano, Alon
AU - Vaknin-Dembinsky, Adi
AU - Mejia Vergara, Alvaro Jose
AU - Wilf-Yarkoni, Adi
AU - Zarco, Luis Alfonso
AU - Zimmermann, Hanna G.
AU - Paul, Friedemann
AU - Stiebel-Kalish, Hadas
N1 - Publisher Copyright:
Copyright © 2023 Asseyer, Asgari, Bennett, Bialer, Blanco, Bosello, Camos-Carreras, Carnero Contentti, Carta, Chen, Chien, Chomba, Dale, Dalmau, Feldmann, Flanagan, Froment Tilikete, Garcia-Alfonso, Havla, Hellmann, Kim, Klyscz, Konietschke, La Morgia, Lana-Peixoto, Leite, Levin, Levy, Llufriu, Lopez, Lotan, Lugaresi, Marignier, Mariotto, Mollan, Ocampo, Cosima Oertel, Olszewska, Palace, Pandit, Peralta Uribe, Pittock, Ramanathan, Rattanathamsakul, Saiz, Samadzadeh, Sanchez-Dalmau, Saylor, Scheel, Schmitz-Hübsch, Shifa, Siritho, Sperber, Subramanian, Tiosano, Vaknin-Dembinsky, Mejia Vergara, Wilf-Yarkoni, Zarco, Zimmermann, Paul and Stiebel-Kalish.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Aquaporin-4-IgG (AQP4-IgG)
KW - MOG-IgG associated disorders (MOGAD)
KW - clinically isolated syndrome (CIS)
KW - multiple sclerosis (MS)
KW - neuromyelitis optica spectrum disorders (NMOSD)
KW - optic neuritis (ON)
UR - https://www.scopus.com/pages/publications/85150165727
U2 - 10.3389/fneur.2023.1102353
DO - 10.3389/fneur.2023.1102353
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C2 - 36908609
AN - SCOPUS:85150165727
SN - 1664-2295
VL - 14
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 1102353
ER -