Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution

Summary

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:

1. In a group of patients with OAG, Citicoline in oral solution (10 ml / day, Neurotidine®) will be administered for 12 months (Citicoline Treated Group, TC Group)
2. in another group of patients with OAG will be administered Placebo (Containing all excipients of Neurotidine ®) (10 ml / day) for 12 months (Placebo Treated Group, TP Group) Randomization will be done by dividing the selected patients into two groups based on similar characteristics of: age, perimetric defect and, mainly, retinal-cortical time (RCT) values.

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).

Conditions

• Primary Open Angle Glaucoma

Interventions

DIETARY_SUPPLEMENT

Citicoline

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.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS

  lead OTHER

Principal Investigators

• Vincenzo VP Parisi, MD · IRCSS Fondazione Bietti

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-25

Primary Completion

2023-12-31

Completion

2025-07-31

Countries

• Italy

Study Locations