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Recruiting NCT05605951

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

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

Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul

Location: United States

Summary

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 undergoclinical examination, including clinical history, neurovisual and neurological testsserum and cerebrospinal fluid examinationoptical 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.

Eligibility Criteria

Inclusion Criteria:First-ever acute ONOnset of visual symptoms within maximum of 30 daysAge ≥ 18 yearsAbility to give written informed consentPresence of written consentExclusion Criteria:MRI contraindicationPrior demyelinating diagnosisDiagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic)Pregnancy at inclusionRelevant other diseases that conflict with study participation according to protocolInability to cooperate

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05605951). StuddyBuddy aggregates publicly available trial information.