An interventional study of Citicoline and Placebo in Primary Open Angle Glaucoma, sponsored by Fondazione G.B. Bietti, IRCCS. Active, not recruiting at 2 sites in Italy. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Fondazione G.B. Bietti, IRCCS · Not applicable, Interventional, and Treatment
A prospective, multicentre, randomized, blinded, masked study that involves the enrollment of 60 patients affected by open angle glaucoma (OAG).
Patients selected according to the inclusion / exclusion criteria, after signing the informed consent, will be randomized into two groups:
Patients will be assigned to each group by an investigator not involved in functional and structural testing.
The key will be opened only at the end of the treatment in order to evaluate the first effects.
The Primary Objective was to evaluate whether treatment with Citicoline in oral solution can produce an improvement of the post-retinal neural conduction, that is delayed in patients with OAG.
The Secondary objective was to evaluate in patients with OAG whether the possible changes in post-retinal neural conduction induced by treatment with Citicoline in oral solution (information obtained through electrophysiological recordings) are associated or not with morphological and functional variations of the nervous structures forming the visual pathways (nucleus geniculatus lateral, optic tract, visual cortex, information obtained through the acquisition of structural and functional magnetic resonance imaging) and whether both conditions can be related to the morpho-functional variations of the retinal ganglion cells and of the visual field (VF).
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will be enrolled in the study within a maximum time frame of 12 months. The enrollment will be performed at T0 (screening), in this occasion an extensive ophthalmological evaluation will be performed after the signature of the informed consent. The patient will be undergoing to the evaluation of Best corrected Visual Acuity (BCVA), intraocular pressure (IOP), fundus examination, Visual Field (VF) exam (Humphrey 24-2and 10-2 standard SITA) Visual Evoked Potentials (VEP) and pattern electroretinogram (PERG). Moreover a morphological examination of optic nerve and macular area was assessed by Optical Coherence Tomography (OCT) with the analysis of retinal nerve fiber layer (RNFL) and retinal ganglion cells (RGCs).
Patients included in the study present a Mean Deviation defect (MD), tested at the VF examination, between -6 and -25 dB and an increase in Retinal-Cortical Time (RCT) response. RCT is a measure derived through the difference of Implicit Time values of latency of simultaneous recording of visual evoked potential (VEP) and pattern electroretinogram (PERG), which represent a post-retinal nerve conduction delay.
About 7-15 days after T0 a new ophthalmological examination will be performed (T1). The patient will be undergoing to the evaluation of BCVA, IOP, fundus examination, VF exam (Humphrey 24-2and 10-2 standard SITA), VEP, PERG and OCT. In this occasion a Magnetic Resonance Imaging (MRI) of the brain will be performed.
At the end of this evaluation, the patient will be given 4 bottles containing 500 ml of Citicoline in oral solution (Neurotidine®) or Placebo and will be given the relative instructions for administration. The posology will be 10 ml once a day in the morning for 6 months. At the end of the 6 month period the patient will be asked to hand over the used bottles.
After 6 months ± 10 days, a novel complete ophthalmologic evaluation will be performed (T2) (BCVA, IOP, VF exam, VEP, PERG, OCT), and patients will be given an additional 4 bottles containing Neurotidine ® or Placebo and will be given instructions for their administration. Again at the end of this 6 month period the patient will bring back the used bottles.
One year after T0, a last complete ophthalmological visit (BCVA, IOP, VF exam, VEP, PERG, OCT) will be performed (T3). In this visit MRI will be repeated. At the end of the visit, the patient will bring back the used bottles. Will be asked to the patient if adverse events will occurs during such period.
943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 710 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Fondazione G.B. Bietti, IRCCS is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In a group of patients with open angle glaucoma (OAG), Citicoline in oral solution (10 ml / day) will be administered for 12 months (Citicoline Treated Group, TC Group)
Dietary Supplement: Citicoline
in another group of patients with open angle glaucoma (OAG) will be administered Placebo (Containing all excipients of Citicoline in oral solution) (10 ml / day) for 12 months (Placebo Treated Group, TP Group)
Dietary Supplement: Placebo
The patient will be given 10 ml of Citicoline oral solution (Neurotidine ®) once a day in the morning for 1 year. To patients will be given 4 bottles containing 500 ml of Citicoline and the relative instructions for administration. After 6 months, the patient will bring back the used bottles and will be given additional 4 bottles containing Citicoline (Neurotidine ®). Again at the end of this 6 month period the patient will bring back the used bottles. Each bottle of Neurotidine will contain: water; fructose; Citicoline (500 mg per 10 ml); acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavine.
The patient will be given 10 ml of an oral solution of Placebo. Each bottle of Placebo, the solution of which will be indistinguishable from the active product in terms of appearance and flavor, will contain: water; fructose; acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavin
Retino-cortical time (RCT) changes after treatment with citicoline in oral solution.
The changes of the retino-cortical time (RCT) in patients affected by open angle glaucoma after one years of treatment with Citicoline in oral solution compared to patients affected by open angle glaucoma treated with placebo.
Time frame: One year
Correlation between RCT changes and morpho-functional parameters changes after treatment with citicoline in oral solution.
In patients with open angle glaucoma, the changes of retino-cortical time (RCT) are associated or not with morphological and functional changes in the nerve structures that form the optical pathways, measured by OCT (RNFL and RGCs), visual field (MD) and magnetic resonance, after one year of treatment with Citicoline in oral solution respect to patients treated with Placebo.
Time frame: one year
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: As soon as possible when the study will be completed. About 6 months after the end of the data collection
Access criteria: The results of this study will be avaiable after end of the study ( 18-24 months) and their publication on a scientific journal.
Ran from Jan 2022 to primary completion in Dec 2023, 23 months.
Of 99 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's 23 months is below that.
Counting every sponsor, half of 172 studies reached it within 33 months; a quarter within 18 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cytidine Diphosphate Choline
Fondazione G.B. Bietti, IRCCS