The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis - Université Jean-Monnet-Saint-Étienne Access content directly
Journal Articles Frontiers in Neurology Year : 2023

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

Susanna Asseyer
  • Function : Author
  • PersonId : 1318452
Nasrin Asgari
  • Function : Author
Jeffrey Bennett
  • Function : Author
Omer Bialer
  • Function : Author
Yolanda Blanco
  • Function : Author
Francesca Bosello
  • Function : Author
Anna Camos-Carreras
  • Function : Author
Edgar Carnero Contentti
  • Function : Author
Sara Carta
  • Function : Author
John Chen
  • Function : Author
Claudia Chien
  • Function : Author
Mashina Chomba
  • Function : Author
Russell Dale
  • Function : Author
Josep Dalmau
  • Function : Author
Kristina Feldmann
  • Function : Author
Eoin Flanagan
  • Function : Author
Carolina Garcia-Alfonso
  • Function : Author
Joachim Havla
  • Function : Author
Mark Hellmann
  • Function : Author
Ho Jin Kim
  • Function : Author
Philipp Klyscz
  • Function : Author
Frank Konietschke
  • Function : Author
Chiara La Morgia
  • Function : Author
Marco Lana-Peixoto
  • Function : Author
Maria Isabel Leite
  • Function : Author
Netta Levin
  • Function : Author
Michael Levy
  • Function : Author
Sara Llufriu
  • Function : Author
Pablo Lopez
  • Function : Author
Itay Lotan
  • Function : Author
Alessandra Lugaresi
  • Function : Author
Romain Marignier
  • Function : Author
Sara Mariotto
  • Function : Author
Susan Mollan
  • Function : Author
Cassandra Ocampo
  • Function : Author
Frederike Cosima Oertel
  • Function : Author
Maja Olszewska
  • Function : Author
Jacqueline Palace
  • Function : Author
Lekha Pandit
  • Function : Author
José Luis Peralta Uribe
  • Function : Author
Sean Pittock
  • Function : Author
Sudarshini Ramanathan
  • Function : Author
Natthapon Rattanathamsakul
  • Function : Author
Albert Saiz
  • Function : Author
Sara Samadzadeh
  • Function : Author
Bernardo Sanchez-Dalmau
  • Function : Author
Deanna Saylor
  • Function : Author
Michael Scheel
  • Function : Author
Tanja Schmitz-Hübsch
  • Function : Author
Jemal Shifa
  • Function : Author
Sasitorn Siritho
  • Function : Author
Pia Sperber
  • Function : Author
Prem Subramanian
  • Function : Author
Alon Tiosano
  • Function : Author
Adi Vaknin-Dembinsky
  • Function : Author
Alvaro Jose Mejia Vergara
  • Function : Author
Adi Wilf-Yarkoni
  • Function : Author
Luis Alfonso Zarco
  • Function : Author
Hanna Zimmermann
  • Function : Author
Friedemann Paul
  • Function : Author
Hadas Stiebel-Kalish
  • Function : Author

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.
Fichier principal
Vignette du fichier
fneur-14-1102353.pdf (1.16 Mo) Télécharger le fichier
Origin : Publisher files allowed on an open archive

Dates and versions

hal-04316068 , version 1 (30-11-2023)

Identifiers

Cite

Susanna Asseyer, Nasrin Asgari, Jeffrey Bennett, Omer Bialer, Yolanda Blanco, et al.. 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, 2023, 14, pp.1102353. ⟨10.3389/fneur.2023.1102353⟩. ⟨hal-04316068⟩
11 View
8 Download

Altmetric

Share

Gmail Facebook X LinkedIn More