Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-arteritic Ischemic Optic Neuropathy

Intervention / Treatment
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* Dietary Supplement: Citicoline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Acute visual reduction episode from NAION occurring for more than 6 months Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2 Visual acuity not less than 1/10 Having suspended any potential neuroprotective therapies (e.g., Coenzyme Q10) for at least 6 months. Exclusion criteria: Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months. Cataract or maculopathy Known hypersensitivity to the study product Positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement Pregnant or nursing women, or women of potential childbearing age not using adequate contraception. Diabetes, SLE, rheumatoid arthritis, mixed connective tissue disease

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAION patients OS-Citicoline treated<br>In a group of patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension | Dietary Supplement: Citicoline<br>* Citicoline administered in oral solution<br>|
| No Intervention: NAION patients untreated<br>In one group of patients with NAION no type of treatment will be performed during 9 months of observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual Acuity at 9 Month | Increase of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR) | 9 months vs baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Retinal Ganglion Cells Function at 9 Month | Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt) | 9 months vs Baseline | 
| Change From Baseline in Optic Nerve Function at 9 Months | Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds | 9 months vs baseline | 
| Change From Baseline in Optic Nerve Morphology at 9 Months | Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron | 9 months vs baseline | 
| Change From Baseline in Visual Field Defects at 9 Months | improvement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB). | 9 months vs baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citicoline, Non-arteritic ischemic optic neuropathy, Neuroprotection, Neuroenhancement