Citicoline Concentration in Human Vitreous

Neurodegenerative Diseases Clinical Trial

Official title:

Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003090
• Other study ID #: N.61/17/FB
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2018
• Source: Istituto di Ricerca Neuroftalmologia S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. The vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.

Description:

At the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy.

Additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (CCT) and corneal endothelial cells density (ECD) evaluations.

Patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery.

Five patients served as controls and received a vehicle solution without citicoline.

The primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography.

Secondary aims were the comparison of citicoline and its metabolites concentration in the vitreous of treated phakic and pseudophakic eyes and the correlations with age and ocular biometric parameters including CCT and ECD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• ability to understand and sign the written informed consent

• diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy

Exclusion Criteria:

• laser treatments and ocular surgery in the past 6 months

• hypersensitivity to the active ingredients used in the study

• other systemic or ocular diseases different from ERM that could affect the outcome of the study

• aphakia or previous complicated cataract surgery

• intraocular lens (IOL) in the anterior chamber

• treatment with systemic citicoline or other potential neuroprotective agents in the past 6 months

• pregnancy or breastfeeding

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Drug:
• Citicoline
After treatment with a solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride patients underwent a 23G standard 3-port pars plana vitrectomy. The vitreous sample was taken at the beginning of the surgery and then analyzed.

Locations

Country	Name	City	State
Italy	Fondazione G.B. Bietti- IRCCS	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Istituto di Ricerca Neuroftalmologia S.r.l.	Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Citicoline and metabolites concentration in human vitreous	Evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration.	14 days
Secondary	Citicoline and metabolites concentration in phakic and pseudophakic eyes	Comparison of citicoline and its metabolites concentration in the vitreous of phakic and pseudophakic eyes and correlations with age, central corneal thickness and corneal endothelial cells density.	14 days