N/A N=40 Randomized Double-blind Treatment

Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Non-arteritic Ischemic Optic Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT03758118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Change From Baseline in Visual Acuity at 9 Month — -0.0574; 0.0535 LogMAR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Citicoline (Dietary_supplement)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Fondazione G.B. Bietti, IRCCS
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Visual Acuity at 9 Month	-0.0574; 0.0535	—
SECONDARY Change From Baseline in Retinal Ganglion Cells Function at 9 Month	1.32; 1.38	—
SECONDARY Change From Baseline in Optic Nerve Function at 9 Months	127.05; 126.88	—
SECONDARY Change From Baseline in Optic Nerve Morphology at 9 Months	57.71; 63.99	—
SECONDARY Change From Baseline in Visual Field Defects at 9 Months	-15.61; -13.02	—

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).

Eligibility Criteria

Inclusion criteria

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03758118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.