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

DOI
https://doi.org/10.3389/fneur.2023.1102353
Journal volume & issue
Vol. 14

Abstract

Read online

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 registrationClinicalTrials.gov, identifier: NCT05605951.

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