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

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Treatment

Placebo

Citicoline

Clinical Study ID

NCT05315206

128/21/FB

Ages 20-70
All Genders

Study 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:

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)
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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 20 and 70 years old
Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey 24-2 standard SITA with mean deviation between -6 and -25 dB) andglaucomatous appearance of the optic nerve
Visual acuity not less than 5/10
Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs includingsympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonicanhydrase inhibitors. Such drugs can be used both alone and in combination with eachother.
Documented post-retinal nerve conduction delay through simultaneous recording of VEPand PERG showing an increase in RCT

Exclusion

Exclusion Criteria:

Ocular surgery in the 3 months preceding the study, including surgery for cataractsin the previous three months.
Cataract or maculopathy
Argon laser trabeculoplasty (ALT) within the previous 6 months
Known hypersensitivity to the study product
Secondary causes of ocular hypertension, including systemic or topical use ofsteroids
Positive history of ocular or systemic diseases that could preclude enrollment inthe study in the opinion of the investigators
Changes in systemic therapies that could compromise intraocular pressure values (beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) inthe 30 days prior to enrollment
Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin,retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and / or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine,Citicoline and / or its derivatives must have been suspended at least 6 months priorto inclusion in the study)
Pregnancy, breastfeeding
Diabetes
Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
Concomitant use of anticoagulants and lithium

Study Design

Placebo

January 25, 2022

July 31, 2025

Study Description

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.

Connect with a study center

Fondazione BIetti, Britannico Hospital
Roma, 00184
Italy
Site Not Available
Fondazione G.B. Bietti-IRCCS
Rome, 00199
Italy
Site Not Available

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