NCT03758118

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
5 years until next milestone

Results Posted

Study results publicly available

November 24, 2023

Completed
Last Updated

November 24, 2023

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

November 27, 2018

Results QC Date

November 28, 2018

Last Update Submit

February 14, 2023

Conditions

Non-arteritic Ischemic Optic Neuropathy

Keywords

CiticolineNon-arteritic ischemic optic neuropathyNeuroprotectionNeuroenhancement

Outcome Measures

Primary Outcomes (1)

  • 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)

    9 months vs baseline

Secondary Outcomes (4)

  • Change From Baseline in Retinal Ganglion Cells Function at 9 Month

    9 months vs Baseline

  • Change From Baseline in Optic Nerve Function at 9 Months

    9 months vs baseline

  • Change From Baseline in Optic Nerve Morphology at 9 Months

    9 months vs baseline

  • Change From Baseline in Visual Field Defects at 9 Months

    9 months vs baseline

Study Arms (2)

NAION patients OS-Citicoline treated

ACTIVE COMPARATOR

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

NAION patients untreated

NO INTERVENTION

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

Interventions

CiticolineDIETARY_SUPPLEMENT

Citicoline administered in oral solution

NAION patients OS-Citicoline treated

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Britannico Hospital

Roma, 00184, Italy

Location

Related Publications (8)

  • 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.

    PMID: 28977448BACKGROUND

  • 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.

    PMID: 29636122BACKGROUND

  • 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.

    PMID: 16286618BACKGROUND

  • 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.

    PMID: 28029908BACKGROUND

  • 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.

    PMID: 18557920BACKGROUND

  • 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.

    PMID: 28861697BACKGROUND

  • 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.

    PMID: 28320183BACKGROUND

  • 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.

    PMID: 31348806DERIVED

MeSH Terms

Interventions

Cytidine Diphosphate Choline

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Results Point of Contact

Title
Dr, Vincenzo Parisi
Organization
IRCCS Fondazione Bietti
vmparisi@gmail.com
+390686356727

Study Officials

  • Vincenzo MF Parisi, MD

    Fondazione Bietti- IRCCS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

February 20, 2017

Primary Completion

July 25, 2017

Study Completion

April 25, 2018

Last Updated

November 24, 2023

Results First Posted

November 24, 2023

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)