Initial Clinical Presentation of Inflammatory Optic Neuritis Associated or Not With Autoantibodies Anti-Myelin-oligodendrocyte-glycoprotein

NCT ID: NCT03345537

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2022-03-31

Brief Summary

In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.

Detailed Description

Optic neuritis (ON) have a broad clinical spectrum ranging from a single episode (clinically isolated ON) to demyelinating diseases such as multiple sclerosis (MS), Chronic Relapsing Inflammatory Optic Neuritis (CRION), acute demyelination encephalomyelitis (ADEM), neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). Myelin oligodendrocyte glycoprotein (MOG) is a myelin antigen exclusively expressed on the surface of oligodendrocytes and myelin in the central nervous system (CNS). MOG-Ab are associated with demyelinating diseases with a good specificity. Using cell-based assays, MOG-Ab were rarely found in healthy control and other neurological inflammatory disease. They were mostly identified in subgroups of NMO/NMOSD seronegative to auto antibodies against Aquaporin 4 (anti-AQP4): 8-39%, but also in MS (0-28%) ADEM and idiopathic ON. ON MOG + have a specific clinical presentation compare with ON associated with multiple sclerosis (SEP): older patient, less female preponderance, more often bilateral, more often optic disc swelling, worse initial visual loss, much more often recurrent with severe sequelae. ON MOG+ are more similar to ON associated with NMOSD AQP4+ which have some particularities: similar age, clear female preponderance, less optic disc swelling, more severe initial visual loss and visual sequelae. No prospective study has measured incidence of

MOG-Ab in population of Inflammatory ON. And no prospective study has ever compared ON MOG+ with all others inflammatory ON. The purpose of our study is to measure incidence of MOG-Ab in population of acute inflammatory ON. All consenting adults with suspicion of ON followed in the 8 ophthalmic units who participate will be screened. They will have, as usual, clinical follow-up, blood test with MOG-Ab research, encephalic and optic nerves MRI, and steroid treatment if necessary. At the end of the acute phase, all patients diagnosed with inflammatory ON will be included and rank in 2 groups: 1/ ON with MOG-Ab (ON MOG+) 2/ ON without MOG-Ab (ON MOG-). Clinical data will be register at this inclusion visit. There will be no additional visit and no intervention. After measuring incidence of MOG-Ab, the investigator will compare clinical and radiological data of ON MOG+ and ON MOG-.

Conditions

Optic Neuritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non interventional study

Non interventional study - only data collected and one blood sample additional

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• legally adult patient
• acute inflammatory optic neuritis
• consent

Exclusion Criteria

• Patient under tutorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Lebranchu, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Chu Angers

Angers, , France

Ch Challans

Challans, , France

Ch Cholet

Cholet, , France

Chd La Roche Sur Yon

La Roche-sur-Yon, , France

Ch Laval

Laval, , France

Chr Le Mans

Le Mans, , France

CHU Nantes

Nantes, , France

Ch Saint Nazaire

Saint-Nazaire, , France

Countries

France

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Other Identifiers

RC17_0250

Identifier Type: -

Identifier Source: org_study_id