Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-02-20
2018-04-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Citicoline
Citicoline administered in oral solution
NAION patients untreated
In one group of patients with NAION no type of treatment will be performed during 9 months of observation
No interventions assigned to this group
Interventions
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Citicoline
Citicoline administered in oral solution
Eligibility Criteria
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Inclusion Criteria
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
* 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
45 Years
80 Years
ALL
Yes
Sponsors
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Fondazione G.B. Bietti, IRCCS
OTHER
Responsible Party
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Principal Investigators
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Vincenzo MF Parisi, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Bietti- IRCCS
Locations
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Britannico Hospital
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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85356727
Identifier Type: -
Identifier Source: org_study_id