Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05605951
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2022-10-23
Brief Title:
Acute Optic Neuritis Network an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve
Sponsor:
Experimental and Clinical Research Center a cooperation between the Max Delbrück Center for Molecul
Organization:
Experimental and Clinical Research Center a cooperation between the Max Delbrück Center for Molecul
Study Overview
Official Title:
The Acute Optic Neuritis Network ACON a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACON
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-IgGON MOG-IgGON 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-IgGON MOG-IgGON and other ON CIS seronegative non-MS-ON to detect diagnostic and predictive markers for the disease course
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-IgGON MOG-IgGON 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-IgGON MOG-IgGON and other ON CIS seronegative non-MS-ON to detect diagnostic and predictive markers for the disease course
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-IgGON or MOG-IgG positive ON MOG-IgGON 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-IgGON or MOG-IgGON 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-IgGON and 50 MOG-IgGON
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
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-IgGON or MOG-IgG positive ON MOG-IgGON 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-IgGON or MOG-IgGON 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-IgGON and 50 MOG-IgGON
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None