NCT03758118

Citicoline in Non-Arteritic Ischemic Optic Neuropathy

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fondazione G.B. Bietti, IRCCS · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-arteritic Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Citicoline	Citicoline administered in oral solution

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-07-25
• Completion: 2018-04-25
• First posted: 2018-11-29
• Last updated: 2023-11-24
• Results posted: 2023-11-24

Locations

1 site across 1 country: Italy