Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
Efgartigimod for the Treatment of Acute Optic Neuritis
Sponsor:
Anastasia Vishnevetsky MD MPH
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Pilot Randomized Trial of Efgartigimod Alfa for the Treatment of Incident Moderate to Severe Acute Optic Neuritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PET-AON
Brief Summary:
The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis optic nerve inflammation The main questions it aims to answer are
Is it feasible to use efgartigimod alfa for optic neuritis
Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis
Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns
Participants will
have their vision and blood tested
be asked questions about their vision
will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not
will have periodic visits over 6 months
Is it feasible to use efgartigimod alfa for optic neuritis
Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis
Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns
Participants will
have their vision and blood tested
be asked questions about their vision
will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not
will have periodic visits over 6 months
Detailed Description:
This study is designed as a pilot single-site randomized placebo-controlled 2-arm parallel-group clinical trial comparing efgartigimod alfa in addition to standard of care IV steroids with a standardized oral taper to standard of care with placebo with an option for rescue therapy with plasma exchange for all participants in the case of poor therapeutic response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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