Trial Outcomes & Findings for Citicoline in Non-Arteritic Ischemic Optic Neuropathy (NCT NCT03758118)
NCT ID: NCT03758118
Last Updated: 2023-11-24
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
9 months vs baseline
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Baseline characteristics by cohort
| Measure |
NAION Patients OS-Citicoline Treated
n=20 eyes
In 20 patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension (NC Group)
|
NAION Patients Untreated
n=20 eyes
In 20 patients with NAION, no type of treatment will be performed during 9 months of observation (NN Group)
|
Total
n=40 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Number of Participants with NAION diagnosis in the last 6 - 12 months
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months vs baselineIncrease of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR)
Outcome measures
| Measure |
NAION Patients OS-Citicoline Treated
n=19 Participants
19 eyes completed the study, 1 eye drop-out
|
NAION Patients Untreated
n=17 Participants
17 eyes completed the study, 3 eyes drop-out
|
|---|---|---|
|
Change From Baseline in Visual Acuity at 9 Month
|
-0.0574 LogMAR
Standard Deviation 0.1147
|
0.0535 LogMAR
Standard Deviation 0.0914
|
SECONDARY outcome
Timeframe: 9 months vs BaselinePattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt)
Outcome measures
| Measure |
NAION Patients OS-Citicoline Treated
n=19 Participants
19 eyes completed the study, 1 eye drop-out
|
NAION Patients Untreated
n=17 Participants
17 eyes completed the study, 3 eyes drop-out
|
|---|---|---|
|
Change From Baseline in Retinal Ganglion Cells Function at 9 Month
|
1.32 microvolt
Standard Deviation 0.39
|
1.38 microvolt
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 9 months vs baselineVisual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds
Outcome measures
| Measure |
NAION Patients OS-Citicoline Treated
n=19 Participants
19 eyes completed the study, 1 eye drop-out
|
NAION Patients Untreated
n=17 Participants
17 eyes completed the study, 3 eyes drop-out
|
|---|---|---|
|
Change From Baseline in Optic Nerve Function at 9 Months
|
127.05 milliseconds
Standard Deviation 8.35
|
126.88 milliseconds
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: 9 months vs baselineReduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron
Outcome measures
| Measure |
NAION Patients OS-Citicoline Treated
n=19 Participants
19 eyes completed the study, 1 eye drop-out
|
NAION Patients Untreated
n=17 Participants
17 eyes completed the study, 3 eyes drop-out
|
|---|---|---|
|
Change From Baseline in Optic Nerve Morphology at 9 Months
|
57.71 micron
Standard Deviation 9.43
|
63.99 micron
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: 9 months vs baselineimprovement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB).
Outcome measures
| Measure |
NAION Patients OS-Citicoline Treated
n=19 Participants
19 eyes completed the study, 1 eye drop-out
|
NAION Patients Untreated
n=17 Participants
17 eyes completed the study, 3 eyes drop-out
|
|---|---|---|
|
Change From Baseline in Visual Field Defects at 9 Months
|
-15.61 dB
Standard Deviation 6.43
|
-13.02 dB
Standard Deviation 7.15
|
Adverse Events
NAION Patients OS-Citicoline Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NAION Patients Untreated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place