Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Fondazione G.B. Bietti, IRCCS

Status: Completed

Conditions: Non-arteritic Ischemic Optic Neuropathy

Treatments: Dietary Supplement: Citicoline

Study type: Interventional

Funder types: Other

Identifiers

NCT03758118

85356727 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

NAION patients OS-Citicoline treated

Active Comparator group

Description:

In a group of patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension

Treatment:

Dietary Supplement: Citicoline

NAION patients untreated

No Intervention group

Description:

In one group of patients with NAION no type of treatment will be performed during 9 months of observation