Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04942002
Status:
UNKNOWN
Last Update Posted:
2021-06-28
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial
Sponsor:
Asociación para Evitar la Ceguera en México
Organization:
Study Overview
Official Title:
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
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:
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Detailed Description:
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Enrollment: 50. Randomized groups (2)
1. Standard treatment + placebo
2. Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
Enrollment: 50. Randomized groups (2)
1. Standard treatment + placebo
2. Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
Study Oversight
Has Oversight DMC:
True
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?: