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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| NAION patients untreated | No Intervention | In one group of patients with NAION no type of treatment will be performed during 9 months of observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Dietary Supplement | Citicoline administered in oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Retinal Ganglion Cells Function at 9 Month | Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt) | 9 months vs Baseline |
| Change From Baseline in Optic Nerve Function at 9 Months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo MF Parisi, MD | Fondazione Bietti- IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Britannico Hospital | Roma | 00184 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28977448 | Background | 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. | |
| 29636122 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAION Patients OS-Citicoline Treated | In 20 patients with NAION, OS-Citicoline was administered (500 mg/day) for 6 months followed by three months of suspension (19 completed the study, NC Group) Citicoline: Citicoline administered in oral solution |
| FG001 | NAION Patients Untreated | In 20 patients with NAION no type of treatment was performed during 9 months of observation (17 patients completed the study, NN Group) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NAION Patients OS-Citicoline Treated | In 20 patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension (NC Group) |
| BG001 | NAION Patients Untreated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | LogMAR | 9 months vs baseline |
|
9 months
No adverse events were observed in any patient enrolled
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAION Patients OS-Citicoline Treated | 19 NAION patients providing 19 eyes completed the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Vincenzo Parisi | IRCCS Fondazione Bietti | +390686356727 | vmparisi@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2016 | Nov 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds
| 9 months vs baseline |
| Change From Baseline in Optic Nerve Morphology at 9 Months | Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron | 9 months vs baseline |
| 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). | 9 months vs baseline |
| 16286618 | Background | 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. |
| 28029908 | Background | 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. |
| 18557920 | Background | 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. |
| 28861697 | Background | 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. |
| 28320183 | Background | 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. |
| 31348806 | Derived | 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. |
In 20 patients with NAION, no type of treatment will be performed during 9 months of observation (NN Group)
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Number of Participants with NAION diagnosis in the last 6 - 12 months | Count of Participants | Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Retinal Ganglion Cells Function at 9 Month | Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt) | Posted | Mean | Standard Deviation | microvolt | 9 months vs Baseline |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | milliseconds | 9 months vs baseline |
|
|
|
| Secondary | Change From Baseline in Optic Nerve Morphology at 9 Months | Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron | Posted | Mean | Standard Deviation | micron | 9 months vs baseline |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | dB | 9 months vs baseline |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | NAION Patients Untreated | 17 NAION patients providing 17 eyes completed the study | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |