NCT05315206Active, not recruiting
Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution
Modulation of Neuronal Connettivity Along the Visual Pathways in Patients Affected by Glaucoma Throug Treatment With Citicoline Oral Solution: Multimodal Morpho-funcional Study
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 4 Feb 2022
- Start date
- 25 Jan 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Diseases
- Glaucoma
- NCT number
- NCT05315206
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 25 Jan 2022 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- 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 prior to inclusion in the study)
- Concomitant use of anticoagulants and lithium
Other illness
- Known hypersensitivity to the study product
- Secondary causes of ocular hypertension, including systemic or topical use of steroids
- Positive history of ocular or systemic diseases that could preclude enrollment in the study in the opinion of the investigators
- Diabetes
Lab values
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- Changes in systemic therapies that could compromise intraocular pressure values (beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the 30 days prior to enrollment
Other
- Cataract or maculopathy
- Pregnancy, breastfeeding
- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
Who the study is looking for
- 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) and glaucomatous appearance of the optic nerve
- Visual acuity not less than 5/10
- Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase inhibitors. Such drugs can be used both alone and in combination with each other.
- Documented post-retinal nerve conduction delay through simultaneous recording of VEP and PERG showing an increase in RCT
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione BIetti, Britannico Hospital Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione G.B. Bietti-IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.