Citicoline Concentration in Human Vitreous

NCT04003090 | Completed

• 1 other identifier: N.61/17/FB
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Keywords

ophthalmic solution; glaucoma; retinal ganglion cells; neuroprotective effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Citicoline and metabolites concentration in phakic and pseudophakic eyes

  14 days

Study Arms (1)

Citicoline eyes

EXPERIMENTAL

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.

Drug: Citicoline

Interventions

Citicoline DRUG

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.

Citicoline eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• ability to understand and sign the written informed consent
• diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto di Ricerca Neuroftalmologia S.r.l.: lead
• Fondazione G.B. Bietti, IRCCS: collaborator

Study Sites (1)

Fondazione G.B. Bietti- IRCCS

Roma, 00198, Italy

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Glaucoma

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Nervous System Diseases; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Francesco Oddone, MD, PHD

  Fondazione G.B. Bietti, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: March 21, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 1, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)