Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve (ACON)
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| ClinicalTrials.gov Identifier: NCT05605951 |
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Recruitment Status :
Recruiting
First Posted : November 4, 2022
Last Update Posted : November 4, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Demyelinating Diseases Multiple Sclerosis Neuromyelitis Optica Spectrum Disorder Attack Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Optic Neuritis | Other: non-interventional study |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis |
| Actual Study Start Date : | August 15, 2020 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
- Other: non-interventional study
observational study
- 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 ]visual acuity
- Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. [ Time Frame: Six months follow-up ]RNFL
- Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. [ Time Frame: Six months follow-up ]MRI lesion score
- Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. [ Time Frame: 12 months follow-up ]MRI lesion score
- 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. [ Time Frame: 12 months follow-up ]RNFL
- 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. [ Time Frame: Acute stage (onset) ]NfL (pg/ml)
- 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. [ Time Frame: Acute stage (onset) ]GFAP (pg/ml)
- 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. [ Time Frame: Six months follow-up ]NfL (pg/ml)
- 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. [ Time Frame: Six months follow-up ]GFAP (pg/ml)
- 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. [ Time Frame: 12 months follow-up ]NfL (pg/ml)
- 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. [ Time Frame: 12 months follow-up ]GFAP (pg/ml)
- 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. [ Time Frame: Acute stage (onset) ]MOG-IgG ratio
- 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. [ Time Frame: Acute stage (onset) ]AQP4-IgG ratio
- 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. [ Time Frame: Six months follow-up ]MOG-IgG IgG ratio
- 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. [ Time Frame: 12 months follow-up ]AQP4-IgG ratio
- Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD. [ Time Frame: Acute stage (onset) ]pRNFL
- Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD. [ Time Frame: Six months follow-up ]pRNFL
- Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up. [ Time Frame: 12 months follow-up ]pRNFL
- Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. [ Time Frame: Acute stage (onset) ]OCT markers
- Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. [ Time Frame: Six months follow-up ]OCT markers
- Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. [ Time Frame: 12 months follow-up ]OCT markers
- Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). [ Time Frame: Acute stage (onset) ]pain intensity
- Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). [ Time Frame: Six months follow-up ]pain intensity
- Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). [ Time Frame: 12 months follow-up ]pain intensity
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: Six months follow-up ]NEI-VFQ-Score
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: 12 months follow-up ]NEI-VFQ-Score
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: Six months follow-up ]BDI-II Score
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: 12 months follow-up ]BDI-II Score
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: Six months follow-up ]EuroQol 5-Dimension EQ-5D-index
- Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. [ Time Frame: 12 months follow-up ]EuroQol 5-Dimension EQ-5D-index
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605951
| Contact: Susanna Asseyer, Dr. med. | 030450639727 | susanna.asseyer@charite.de | |
| Contact: Hadas Stiebel-Kalish, Prof. | kalishhadas@gmail.com |
Show 26 study locations
| Principal Investigator: | Susanna Asseyer | Charite University, Berlin, Germany | |
| Principal Investigator: | Hadas Stiebel-Kalish | Rabin Medical Center, Tel Aviv |
| Responsible Party: | Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul |
| ClinicalTrials.gov Identifier: | NCT05605951 |
| Other Study ID Numbers: |
ACON2022 |
| First Posted: | November 4, 2022 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Sclerosis Neuritis Neuromyelitis Optica Optic Neuritis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Myelitis, Transverse Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases |