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Non-arteritic Ischemic Optic NeuropathyNCT03758118

Citicoline in Non-Arteritic Ischemic Optic Neuropathy

A study testing Citicoline in people with Non-arteritic Ischemic Optic Neuropathy, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Non-arteritic Ischemic Optic Neuropathy
What is being tested?
Citicoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
20 Feb 2017to 25 Apr 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Britannico Hospital

    Roma, 00184

Other trials in Italy

About this study

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

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).

Read the detailed 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.

Being tested
Citicoline
Keywords
Citicoline, Non-arteritic ischemic optic neuropathy, Neuroprotection, Neuroenhancement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiticolineDietary supplement

    Citicoline administered in oral solution

Study groups in NCT03758118
Study groupRoleWhat they receive
NAION patients OS-Citicoline treatedActive comparatorIn a group of patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension
Receives: Dietary Supplement: Citicoline
NAION patients untreatedNo interventionIn one group of patients with NAION no type of treatment will be performed during 9 months of observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 9 months vs baseline

Secondary outcomes (4)

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

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

    Measured: 9 months vs Baseline

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

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

    Measured: 9 months vs baseline

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

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

    Measured: 9 months vs baseline

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

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

    Measured: 9 months vs baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2018
  2. Study start20 Feb 2017
  3. Primary completion25 Jul 2017
  4. Study completion25 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03758118
Sponsor's protocol ID
85356727
Status last verified
Feb 2021
First submitted
27 Nov 2018
Last updated
24 Nov 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28977448

  • 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.

    PubMed 29636122

  • 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.

    PubMed 16286618

  • 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.

    PubMed 28029908

  • 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.

    PubMed 18557920

  • 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.

    PubMed 28861697

  • 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.

    PubMed 28320183

  • 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.

    PubMed 31348806

Questions about this trial

What is this clinical trial studying?

A study testing Citicoline in people with Non-arteritic Ischemic Optic Neuropathy, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Visual Acuity at 9 Month (time frame: 9 months vs baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758118, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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