Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT03758118
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2018-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Sponsor:
Fondazione G.B. Bietti, IRCCS
Organization:
Study Overview
Official Title:
Neuroprotection and Neuroenhancement in a Model of Optic Nerve Neurodegeneration (Non Arteritic Ischemic Optic Neuropathy): Study of Morpho-functional Changes Related to Treatment With Citicoline Oral Solution
Status:
COMPLETED
Status Verified Date:
2021-02
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:
The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).
Detailed Description:
The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar controls
Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.
Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.
Study Oversight
Has Oversight DMC:
False
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?: