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Citicoline Concentration in Human Vitreous

Primary Purpose

Neurodegenerative Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Citicoline
Sponsored by
Istituto di Ricerca Neuroftalmologia S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodegenerative Diseases focused on measuring ophthalmic solution, glaucoma, retinal ganglion cells, neuroprotective effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione G.B. Bietti- IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Citicoline eyes

Arm Description

Patients had to administer 3 drops/day of an ophthalmic solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride for 14 days before surgery and 2 hours prior to surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2019
Last Updated
June 27, 2019
Sponsor
Istituto di Ricerca Neuroftalmologia S.r.l.
Collaborators
Fondazione G.B. Bietti, IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT04003090
Brief Title
Citicoline Concentration in Human Vitreous
Official Title
Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto di Ricerca Neuroftalmologia S.r.l.
Collaborators
Fondazione G.B. Bietti, IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases
Keywords
ophthalmic solution, glaucoma, retinal ganglion cells, neuroprotective effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citicoline eyes
Arm Type
Experimental
Arm Description
Patients had to administer 3 drops/day of an ophthalmic solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride for 14 days before surgery and 2 hours prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Citicoline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Citicoline and metabolites concentration in human vitreous
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Citicoline and metabolites concentration in phakic and pseudophakic eyes
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Oddone, MD, PHD
Organizational Affiliation
Fondazione G.B. Bietti, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione G.B. Bietti- IRCCS
City
Roma
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Citicoline Concentration in Human Vitreous

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