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Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Primary Purpose

Non-arteritic Ischemic Optic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Citicoline
Sponsored by
Fondazione G.B. Bietti, IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-arteritic Ischemic Optic Neuropathy focused on measuring Citicoline, Non-arteritic ischemic optic neuropathy, Neuroprotection, Neuroenhancement

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Britannico Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NAION patients OS-Citicoline treated

NAION patients untreated

Arm 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

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

Outcomes

Primary Outcome Measures

Stabilization or amelioration of Visual Acuity
Visual Acuity measured as LogMAR

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2018
Last Updated
November 27, 2018
Sponsor
Fondazione G.B. Bietti, IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT03758118
Brief Title
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione G.B. Bietti, IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-arteritic Ischemic Optic Neuropathy
Keywords
Citicoline, Non-arteritic ischemic optic neuropathy, Neuroprotection, Neuroenhancement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAION patients OS-Citicoline treated
Arm Type
Active Comparator
Arm 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
Arm Title
NAION patients untreated
Arm Type
No Intervention
Arm Description
In one group of patients with NAION no type of treatment will be performed during 9 months of observation
Intervention Type
Dietary Supplement
Intervention Name(s)
Citicoline
Intervention Description
Citicoline administered in oral solution
Primary Outcome Measure Information:
Title
Stabilization or amelioration of Visual Acuity
Description
Visual Acuity measured as LogMAR
Time Frame
0-9 months
Secondary Outcome Measure Information:
Title
Stabilization or amelioration of Retinal Ganglion Cells function
Description
Pattern-Electroretinogram recordings. The main parameter is the P50-N95 amplitude measured in microvolt.
Time Frame
0-9 months
Title
Stabilization or amelioration of optic nerve function
Description
Visual Evoked Potentials recordings. The main parameter is the P100 Implicit time measured in milliseconds
Time Frame
0-9 months
Title
Stabilization or amelioration of optic nerve morphology
Description
Assessment of Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron
Time Frame
0-9 months
Title
Stabilization or amelioration of the visual field
Description
evaluation of the visual field by static perimetry (the main indexes are Mean Deviation and Pattern Standard Deviation measured in dB).
Time Frame
0-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo MF Parisi, MD
Organizational Affiliation
Fondazione Bietti- IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Britannico Hospital
City
Roma
ZIP/Postal Code
00184
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28977448
Citation
Carelli V, La Morgia C, Ross-Cisneros FN, Sadun AA. Optic neuropathies: the tip of the neurodegeneration iceberg. Hum Mol Genet. 2017 Oct 1;26(R2):R139-R150. doi: 10.1093/hmg/ddx273.
Results Reference
result
PubMed Identifier
29636122
Citation
Cho YS. The role of necroptosis in the treatment of diseases. BMB Rep. 2018 May;51(5):219-224. doi: 10.5483/bmbrep.2018.51.5.074.
Results Reference
result
PubMed Identifier
16286618
Citation
Hayreh SS, Zimmerman B. Visual field abnormalities in nonarteritic anterior ischemic optic neuropathy: their pattern and prevalence at initial examination. Arch Ophthalmol. 2005 Nov;123(11):1554-62. doi: 10.1001/archopht.123.11.1554.
Results Reference
result
PubMed Identifier
28029908
Citation
Patel HR, Margo CE. Pathology of Ischemic Optic Neuropathy. Arch Pathol Lab Med. 2017 Jan;141(1):162-166. doi: 10.5858/arpa.2016-0027-RS.
Results Reference
result
PubMed Identifier
18557920
Citation
Parisi V, Gallinaro G, Ziccardi L, Coppola G. Electrophysiological assessment of visual function in patients with non-arteritic ischaemic optic neuropathy. Eur J Neurol. 2008 Aug;15(8):839-45. doi: 10.1111/j.1468-1331.2008.02200.x. Epub 2008 Jun 28.
Results Reference
result
PubMed Identifier
28861697
Citation
Balducci N, Morara M, Veronese C, Barboni P, Casadei NL, Savini G, Parisi V, Sadun AA, Ciardella A. Optical coherence tomography angiography in acute arteritic and non-arteritic anterior ischemic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2017 Nov;255(11):2255-2261. doi: 10.1007/s00417-017-3774-y. Epub 2017 Aug 31.
Results Reference
result
PubMed Identifier
28320183
Citation
Khalilpour S, Latifi S, Behnammanesh G, Majid AMSA, Majid ASA, Tamayol A. Ischemic optic neuropathy as a model of neurodegenerative disorder: A review of pathogenic mechanism of axonal degeneration and the role of neuroprotection. J Neurol Sci. 2017 Apr 15;375:430-441. doi: 10.1016/j.jns.2016.12.044. Epub 2016 Dec 26.
Results Reference
result
PubMed Identifier
31348806
Citation
Parisi V, Barbano L, Di Renzo A, Coppola G, Ziccardi L. Neuroenhancement and neuroprotection by oral solution citicoline in non-arteritic ischemic optic neuropathy as a model of neurodegeneration: A randomized pilot study. PLoS One. 2019 Jul 26;14(7):e0220435. doi: 10.1371/journal.pone.0220435. eCollection 2019. Erratum In: PLoS One. 2019 Aug 14;14(8):e0221313.
Results Reference
derived

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Citicoline in Non-Arteritic Ischemic Optic Neuropathy

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