Skip to main content
OpenTrials
Completed

NCT Number: NCT03758118

Citicoline in Non-Arteritic Ischemic Optic Neuropathy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-arteritic Ischemic Optic Neuropathy

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Britannico Hospital

Roma, 00184, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citicoline

Dietary Supplement

Citicoline administered in oral solution

Primary outcomes

  1. Change From Baseline in Visual Acuity at 9 Month

    Time frame: 9 months vs baseline

    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)

Secondary outcomes

  1. Change From Baseline in Retinal Ganglion Cells Function at 9 Month

    Time frame: 9 months vs Baseline

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

  2. Change From Baseline in Optic Nerve Function at 9 Months

    Time frame: 9 months vs baseline

    Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds

  3. Change From Baseline in Optic Nerve Morphology at 9 Months

    Time frame: 9 months vs baseline

    Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron

  4. Change From Baseline in Visual Field Defects at 9 Months

    Time frame: 9 months vs baseline

    improvement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB).

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.