Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Fondazione G.B. Bietti, IRCCS40 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-arteritic Ischemic Optic Neuropathy

Interventions

CiticolineDIETARY_SUPPLEMENT

Citicoline administered in oral solution

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Acute visual reduction episode from NAION occurring for more than 6 months 2. Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2 3. Visual acuity not less than 1/10 4. 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

Locations (1)

Britannico Hospital

Roma, Italy

Outcomes

Primary Outcomes

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)

Time frame: 9 months vs baseline

Secondary Outcomes

Change From Baseline in Retinal Ganglion Cells Function at 9 Month

Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt)

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 9 months vs baseline

Data from ClinicalTrials.gov

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