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Demyelinating DiseasesACONNCT05605951

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

An observational study of Demyelinating Diseases and Multiple Sclerosis, run by Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul at 26 sites in 17 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
non-interventional study
How many people
200 participants
Where
26 sitesin 17 countries
Study dates
15 Aug 2020to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

26 sites in 17 countries.

Susanna Asseyer, Dr. med. contact

030450639727

susanna.asseyer@charite.de

Hadas Stiebel-Kalish, Prof. contact

kalishhadas@gmail.com

26 sites in 17 countries

United States3 sites, 3 recruiting

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

    Jeffrey Bennett, Prof.

    Jeffrey Bennett, Prof.

    Not yet recruiting

  • Harvard Medical School

    Boston, Massachusetts, 02115

    Michael Levy, Prof.

    Michael Levy, Prof.

    Not yet recruiting

  • Departments of Neurology and Ophthalmology, Mayo Clinic

    Rochester, Minnesota, 55902

    John Chen, Prof.

    Sean Pittock, Prof.

    Recruiting

Other trials in United States

Colombia3 sites, 3 recruiting

  • Del Rosario University

    Bogotá

    Rodrigo Gonzales-Reyes, Dr.

    Rodrigo Gonzales-Reyes

    Not yet recruiting

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

    Bogotá

    Alvaro Jose Mejia Vergara

    Not yet recruiting

  • Pontificia Universidad Javeriana

    Bogotá

    Luis Alfonso Zarco Montero, Dr.

    Luis Alfonso Zarco Montero, Dr.

    Not yet recruiting

Other trials in Colombia

Germany2 sites, 2 recruiting

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

    Berlin

    Susanna Asseyer, Dr.

    Susanna Asseyer, Dr.

    Recruiting

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

    Munich

    Joachim Havla, Prof.

    Joachim Havla, Prof.

    Not yet recruiting

Other trials in Germany

Israel2 sites, 2 recruiting

  • Hadassah Hebrew University

    Jerusalem

    Netta Levin, Prof.

    Netta Levin, Prof.

    Not yet recruiting

  • Sackler School of Medicine and Rabin Medical Center

    Tel Aviv

    Hadas Stiebel-Kalish, Prof., kalishhadas@gmail.com

    Hadas Stiebel-Kalish, Prof.

    Recruiting

Other trials in Israel

Italy2 sites, 2 recruiting

  • University of Bologna

    Bologna

    Alessandra Lugaressi, Prof.

    Alessandra Lugaressi, Prof.

    Not yet recruiting

  • University of Verona

    Verona

    Sara Mariotto, Dr.

    Sara Mariotto

    Recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

  • University of Barcelona

    Barcelona

    Josep Dalmau, Prof.

    Josep Dalmau, Prof.

    Not yet recruiting

  • Vall d'Hebron Barcelona Hospital Campus

    Barcelona

    Vidal Angela, Dr.

    Vidal Angela, Dr.

    Not yet recruiting

Other trials in Spain

United Kingdom2 sites, 2 recruiting

  • University Hospitals of Birmingham

    Birmingham

    Susan Mollan, Dr.

    Susan Mollan, Dr.

    Not yet recruiting

  • Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

    Oxford

    Jacqueline Palace, Prof.

    Jacqueline Palace, Prof.

    Not yet recruiting

Other trials in United Kingdom

Argentina1 site, 1 recruiting

  • Hospital Aleman

    Buenos Aires

    Edgar Carnero Contentti, Dr.

    Dr.

    Not yet recruiting

Other trials in Argentina

Australia1 site, 1 recruiting

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

    Sydney

    Sundarshini Ramanathan, Dr.

    Sundarshini Ramanathan, Dr.

    Recruiting

Other trials in Australia

Botswana1 site, 1 recruiting

  • University of Botswana

    Gaborone

    Cassandra Ocampo, Dr.

    Cassandra Ocampo, Dr.

    Not yet recruiting

Other trials in Botswana

Brazil1 site, 1 recruiting

  • Federal University of Minas Gerais, Belo Horizonte

    Minas Gerais

    Marco Lana-Peixoto, Prof.

    Marco Lana-Peixoto, Prof.

    Not yet recruiting

Other trials in Brazil

Denmark1 site, 1 recruiting

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

    Odense

    Nasrin Asgari, Prof.

    Nasrin Asgari, Prof.

    Recruiting

Other trials in Denmark

France1 site, 1 recruiting

  • (MIRCEM) Lyon Civil Hospices, France

    Lyon

    Carolin Froment Tilikete, Dr.

    Carolin Froment Tilikete, Dr.

    Not yet recruiting

Other trials in France

India1 site, 1 recruiting

  • Nitte University, Karnataka

    Mangalore

    Lekha Pandit, Prof.

    Lehka Pandit, Prof.

    Not yet recruiting

Other trials in India

Japan1 site, 1 recruiting

  • Fukushima Medical University School of Medicine

    Fukushima

    Kazuo Fujihara, Prof.

    Kazuo Fujihara, Prof.

    Not yet recruiting

Other trials in Japan

South Korea1 site, 1 recruiting

  • National Cancer Center, Seúl University

    Seoul

    Ho Jin Kim, Prof.

    Ho Jin Kim, Prof.

    Not yet recruiting

Other trials in South Korea

Zambia1 site, 1 recruiting

  • University Teaching Hospital in Lusaka

    Lusaka

    Deanna Saylor, Dr.

    Deanna Saylor, Dr.

    Not yet recruiting

Other trials in Zambia

About this study

Official title: The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis

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.
Read the detailed description

The Acute Optic Neuritis Network (ACON) is a global cooperation of currently 26 academic centers longitudinally investigating subjects with inaugural acute optic neuritis (ON). ON often occurs at 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 ACON study is primarily designed to investigate the effect of time to high-dose corticosteroid treatment on 6-month visual outcomes in ON.

All patients presenting within 30 days of inaugural ON will be enrolled. For primary analysis, patients will subsequently be assigned either into the MS-ON, aquaporin-4-IgG positive ON (AQP4-IgG+ON) or MOG-IgG positive ON (MOG-IgG+ON) group and then further sub-stratified according to the number of days from onset of visual loss to high-dose corticosteroids. The primary outcome measure will be high-contrast best-corrected visual acuity (HC-BCVA) at 6 months. Additionally, 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: optical coherence tomography (OCT) and magnetic resonance imaging (MRI) measurements, serum and cerebrospinal fluid (CSF) biomarkers (AQP4- and MOG-IgG levels; neurofilament; glial fibrillary protein), questionnaires (headache, visual function in daily routine, depression, and quality of life) at presentation, at 6- and 12-months follow-up. Data will be collected from 22 academic hospitals from Africa, Asia, the Middle East, Europe, North America, South America, Australia and Europe. 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 accuracy of diagnostic stratification in acute demyelinating ON.

Being tested
non-interventional study
Medical subject headings
Demyelinating Diseases, Multiple Sclerosis, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Optic Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-interventional studyOther

    observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Six months follow-up

Secondary outcomes (29)

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

    RNFL

    Measured: Six months follow-up

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

    MRI lesion score

    Measured: Six months follow-up

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

    MRI lesion score

    Measured: 12 months follow-up

  4. 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.

    RNFL

    Measured: 12 months follow-up

  5. 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.

    NfL (pg/ml)

    Measured: Acute stage (onset)

  6. 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.

    GFAP (pg/ml)

    Measured: Acute stage (onset)

  7. 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.

    NfL (pg/ml)

    Measured: Six months follow-up

  8. 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.

    GFAP (pg/ml)

    Measured: Six months follow-up

  9. 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.

    NfL (pg/ml)

    Measured: 12 months follow-up

  10. 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.

    GFAP (pg/ml)

    Measured: 12 months follow-up

  11. Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.

    MOG-IgG ratio

    Measured: Acute stage (onset)

  12. Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.

    AQP4-IgG ratio

    Measured: Acute stage (onset)

  13. Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.

    MOG-IgG IgG ratio

    Measured: Six months follow-up

  14. Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.

    AQP4-IgG ratio

    Measured: 12 months follow-up

  15. Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.

    pRNFL

    Measured: Acute stage (onset)

  16. Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.

    pRNFL

    Measured: Six months follow-up

  17. Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up.

    pRNFL

    Measured: 12 months follow-up

  18. Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.

    OCT markers

    Measured: Acute stage (onset)

  19. Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.

    OCT markers

    Measured: Six months follow-up

  20. Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.

    OCT markers

    Measured: 12 months follow-up

  21. Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).

    pain intensity

    Measured: Acute stage (onset)

  22. Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).

    pain intensity

    Measured: Six months follow-up

  23. Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).

    pain intensity

    Measured: 12 months follow-up

  24. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    NEI-VFQ-Score

    Measured: Six months follow-up

  25. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    NEI-VFQ-Score

    Measured: 12 months follow-up

  26. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    BDI-II Score

    Measured: Six months follow-up

  27. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    BDI-II Score

    Measured: 12 months follow-up

  28. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    EuroQol 5-Dimension EQ-5D-index

    Measured: Six months follow-up

  29. Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.

    EuroQol 5-Dimension EQ-5D-index

    Measured: 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start15 Aug 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605951
Sponsor's protocol ID
ACON2022
Acronym
ACON
Status last verified
Oct 2022
First submitted
23 Oct 2022
Last updated
4 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request

Publications

  • 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.

    PubMed 36908609

Questions about this trial

What is this clinical trial studying?

An observational study of Demyelinating Diseases and Multiple Sclerosis, run by Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul at 26 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Colombia, Germany, Israel, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Susanna Asseyer, Dr. med. (030450639727, susanna.asseyer@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Six months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605951, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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