Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Non-arteritic Ischemic Optic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758118
• Other study ID #: 85356727
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: February 2021
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 25, 2018
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Non-arteritic Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Peripheral Nervous System Diseases

Intervention

Dietary Supplement:
• Citicoline
Citicoline administered in oral solution

Locations

Country	Name	City	State
Italy	Britannico Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	9 months vs baseline
Secondary	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
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	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	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).	9 months vs baseline