Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167642
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-12
First Post:
2023-11-15
Brief Title:
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
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:
None
Brief Summary:
This study aims to assess whether and the degree to which ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS RMS according to baseline serum neurofilament light chain sNfL levels
Detailed Description:
Seventy-five people with RMS who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited All recruited participants will be tracked prospectively over a two-year period Participants will complete an optical coherence tomography OCT scan visual acuity VA assessments EDSS and sNfL blood level at baseline and every 6 months Participants will be tracked prospectively for 2 years OCT scans sNfL levels disability score determinations 100 high-contrast 25 and 125 low-contrast letter acuities will be performed every 6 months Results from an existing cohort of approximately 75 healthy controls HC from a separate study undergoing annual OCT and visual function assessments will be used for comparison purposes
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?:
False
Is an FDA AA801 Violation?:
None