Status:
COMPLETED
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Non-arteritic Ischemic Optic Neuropathy
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief 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 neu...
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-m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03758118
Start Date
February 20 2017
End Date
April 25 2018
Last Update
November 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Britannico Hospital
Roma, Italy, 00184