Citicoline in Non-Arteritic Ischemic Optic Neuropathy

November 27, 2018 updated by: Fondazione G.B. Bietti, IRCCS

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators enrolled 36 patients with bilateral or monolateral NAION and 20 age similar controls. Nineteen NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (NC Group); 17 NAION patients were not treated (NN Group) from baseline up to 9 months. We assessed 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). Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00184
        • Britannico Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NAION patients OS-Citicoline treated
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
Citicoline administered in oral solution
No Intervention: NAION patients untreated
In one group of patients with NAION no type of treatment will be performed during 9 months of observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stabilization or amelioration of Visual Acuity
Time Frame: 0-9 months
Visual Acuity measured as LogMAR
0-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stabilization or amelioration of Retinal Ganglion Cells function
Time Frame: 0-9 months
Pattern-Electroretinogram recordings. The main parameter is the P50-N95 amplitude measured in microvolt.
0-9 months
Stabilization or amelioration of optic nerve function
Time Frame: 0-9 months
Visual Evoked Potentials recordings. The main parameter is the P100 Implicit time measured in milliseconds
0-9 months
Stabilization or amelioration of optic nerve morphology
Time Frame: 0-9 months
Assessment of Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron
0-9 months
Stabilization or amelioration of the visual field
Time Frame: 0-9 months
evaluation of the visual field by static perimetry (the main indexes are Mean Deviation and Pattern Standard Deviation measured in dB).
0-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione G.B. Bietti, IRCCS

Investigators

  • Principal Investigator: Vincenzo MF Parisi, MD, Fondazione Bietti- IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Actual)

July 25, 2017

Study Completion (Actual)

July 25, 2017

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85356727 (FGBBIETTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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