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

NCT05605951 | Unknown

• 1 other identifier: ACON2022
• Study Type: observational
• Target: 200
• Locations: 17 countries
• Sites: 26

Brief 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• to investigate whether MS-ON, AQP4-IgG+ON and MOG-IgG+ON patients treated with early high-dose corticosteroids for visual loss have better visual outcomes and QoL than those with late treatment.

  visual acuity

  Six months follow-up

Secondary Outcomes (29)

• Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.

  Six months follow-up

• Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.

  Six months follow-up

• Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.

  12 months follow-up

• Visual and structural outcomes of MS-ON in patients treated with high-dose corticosteroid-therapy with oral prednisone taper vs. without taper as standard of care.

  12 months follow-up

• Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.

  Acute stage (onset)

Interventions

non-interventional study OTHER

observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 300 patients with acute ON will be screened for study eligibility. We will include only inaugural ON patients. Subjects presenting for the first time with isolated ON or ON with additional demyelinating syndromes, e.g. myelitis or acute disseminated encephalomyelitis (ADEM) occurring within 30 days of the acute ON will be included. Patients with prior soft symptoms which can retrospectively be considered to be a demyelinating manifestation will be included, excluding patients with a prior demyelinating diagnosis. The prevalence of MS-, AQP4-IgG+ON and MOG-IgG+ON differs in each of the participating centers. For primary analysis, we collect data from subjects with MS-ON, AQP4-IgG+ON and MOG-IgG+ON. For secondary analysis, multimodal data will be collected in subjects with any demyelinating ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON). We expect between 30-50% will be ineligible due to the rigorous exclusion criteria.

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)
• Relevant other diseases that conflict with study participation according to protocol
• Inability to cooperate

Sponsors & Collaborators

• Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul: lead

Study Sites (26)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Harvard Medical School

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Departments of Neurology and Ophthalmology, Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Hospital Aleman

Buenos Aires, Argentina

NOT YET RECRUITING

Department of Neurology, Concord Hospital, Faculty of Medicine and Health

Sydney, Australia

RECRUITING

University of Botswana

Gaborone, Botswana

NOT YET RECRUITING

Federal University of Minas Gerais, Belo Horizonte

Minas Gerais, Brazil

NOT YET RECRUITING

Del Rosario University

Bogotá, Colombia

NOT YET RECRUITING

Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas

Bogotá, Colombia

NOT YET RECRUITING

Pontificia Universidad Javeriana

Bogotá, Colombia

NOT YET RECRUITING

Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark

Odense, Denmark

RECRUITING

(MIRCEM) Lyon Civil Hospices, France

Lyon, France

NOT YET RECRUITING

Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany, Department of Neurology

Berlin, Germany

RECRUITING

Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich

Munich, Germany

NOT YET RECRUITING

Nitte University, Karnataka

Mangalore, India

NOT YET RECRUITING

Hadassah Hebrew University

Jerusalem, Israel

NOT YET RECRUITING

Sackler School of Medicine and Rabin Medical Center

Tel Aviv, Israel

RECRUITING

University of Bologna

Bologna, Italy

NOT YET RECRUITING

University of Verona

Verona, Italy

RECRUITING

Fukushima Medical University School of Medicine

Fukushima, Japan

NOT YET RECRUITING

National Cancer Center, Seúl University

Seoul, South Korea

NOT YET RECRUITING

University of Barcelona

Barcelona, Spain

NOT YET RECRUITING

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Spain

NOT YET RECRUITING

University Hospitals of Birmingham

Birmingham, United Kingdom

NOT YET RECRUITING

Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

Oxford, United Kingdom

NOT YET RECRUITING

University Teaching Hospital in Lusaka

Lusaka, Zambia

NOT YET RECRUITING

Related Publications (1)

• Asseyer S, Asgari N, Bennett J, Bialer O, Blanco Y, Bosello F, Camos-Carreras A, Carnero Contentti E, Carta S, Chen J, Chien C, Chomba M, Dale RC, Dalmau J, Feldmann K, Flanagan EP, Froment Tilikete C, Garcia-Alfonso C, Havla J, Hellmann M, Kim HJ, Klyscz P, Konietschke F, La Morgia C, Lana-Peixoto M, Leite MI, Levin N, Levy M, Llufriu S, Lopez P, Lotan I, Lugaresi A, Marignier R, Mariotto S, Mollan SP, Ocampo C, Cosima Oertel F, Olszewska M, Palace J, Pandit L, Peralta Uribe JL, Pittock S, Ramanathan S, Rattanathamsakul N, Saiz A, Samadzadeh S, Sanchez-Dalmau B, Saylor D, Scheel M, Schmitz-Hubsch T, Shifa J, Siritho S, Sperber PS, Subramanian PS, Tiosano A, Vaknin-Dembinsky A, Mejia Vergara AJ, Wilf-Yarkoni A, Zarco LA, Zimmermann HG, Paul F, Stiebel-Kalish H. The Acute Optic Neuritis Network (ACON): Study protocol of a non-interventional prospective multicenter study on diagnosis and treatment of acute optic neuritis. Front Neurol. 2023 Feb 24;14:1102353. doi: 10.3389/fneur.2023.1102353. eCollection 2023.

  PMID: 36908609 DERIVED

MeSH Terms

Conditions

Demyelinating Diseases; Multiple Sclerosis; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Optic Neuritis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Susanna Asseyer

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Hadas Stiebel-Kalish

  Rabin Medical Center, Tel Aviv

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Asseyer, Dr. med.

CONTACT

030450639727; susanna.asseyer@charite.de

Hadas Stiebel-Kalish, Prof.

CONTACT

kalishhadas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 4, 2022
• Study Start: August 15, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (3); ES (2); AR (1); BR (1); BO (1); IT (2); JP (1); DE (2); DK (1); ZA (1); IN (1); KR (1); FR (1); GB (2); IL (2); CO (3)