Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve

Status unconfirmed

Conditions studied: Demyelinating Diseases, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder Attack, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Optic Neuritis

In brief

The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON). The main questions it aims to answer are: * Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON? * How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo * clinical examination, including clinical history, neurovisual and neurological tests * serum and cerebrospinal fluid examination * optical coherence tomography (OCT) * magnetic resonance imaging (MRI) * assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.

Key facts

Study ID: NCT05605951
Run by: Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul
People needed: 200
Starts: 2020-08-15
Expected to finish: 2025-12-31
Last updated by the study team: 2022-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

First-ever acute ON
Onset of visual symptoms within maximum of 30 days
Age ≥ 18 years
Ability to give written informed consent
Presence of written consent

You may not qualify if…

MRI contraindication
Prior demyelinating diagnosis
Diagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic)
Pregnancy at inclusion
Relevant other diseases that conflict with study participation according to protocol
Inability to cooperate

Where it is running

Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark — Odense, Denmark (enrolling)
Department of Neurology, Concord Hospital, Faculty of Medicine and Health — Sydney, Australia (enrolling)
Sackler School of Medicine and Rabin Medical Center — Tel Aviv, Israel (enrolling)
Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany, Department of Neurology — Berlin, Germany (enrolling)
University of Verona — Verona, Italy (enrolling)
Departments of Neurology and Ophthalmology, Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas — Bogotá, Colombia
Pontificia Universidad Javeriana — Bogotá, Colombia
(MIRCEM) Lyon Civil Hospices, France — Lyon, France
Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich — Munich, Germany
Nitte University, Karnataka — Mangalore, India
Hadassah Hebrew University — Jerusalem, Israel
University of Bologna — Bologna, Italy
Fukushima Medical University School of Medicine — Fukushima, Japan
National Cancer Center, Seúl University — Seoul, South Korea
University of Barcelona — Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus — Barcelona, Spain
University Hospitals of Birmingham — Birmingham, United Kingdom
Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital — Oxford, United Kingdom
University of Colorado School of Medicine — Aurora, Colorado, United States
University Teaching Hospital in Lusaka — Lusaka, Zambia
Harvard Medical School — Boston, Massachusetts, United States
Hospital Aleman — Buenos Aires, Argentina
University of Botswana — Gaborone, Botswana
Federal University of Minas Gerais, Belo Horizonte — Minas Gerais, Brazil

Full record on ClinicalTrials.gov

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