Neurodegenerative DiseasesNCT04003090
Citicoline Concentration in Human Vitreous
A study testing Citicoline in people with Neurodegenerative Diseases, run by Istituto di Ricerca Neuroftalmologia S.r.l. at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- Citicoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- ability to understand and sign the written informed consent
- diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study
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.
Read the 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.
- Conditions
- Neurodegenerative Diseases
- Being tested
- Citicoline
- Keywords
- ophthalmic solution, glaucoma, retinal ganglion cells, neuroprotective effect
- Medical subject headings
- Neurodegenerative Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Citicoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start21 Mar 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto di Ricerca Neuroftalmologia S.r.l.
- Sponsor type
- Research network
- Collaborators
- Fondazione G.B. Bietti, IRCCS
- Responsible party
- Sponsor
- Investigators
- Francesco Oddone, MD, PHD, Principal investigator, Fondazione G.B. Bietti, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003090
- Sponsor's protocol ID
- N.61/17/FB
- Status last verified
- Mar 2018
- First submitted
- 27 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04003090
- Acronym / sponsor ID
- N.61/17/FB
- Conditions
- Neurodegenerative Diseases
- Keywords
- ophthalmic solution, glaucoma, retinal ganglion cells, neuroprotective effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istituto di Ricerca Neuroftalmologia S.r.l.Research network
- Collaborators
- Fondazione G.B. Bietti, IRCCS
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Citicoline eyes | Experimental | Drug: CiticolinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- ability to understand and sign the written informed consent
- diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineAfter 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. | Drug | Citicoline eyes |
Primary outcome
Citicoline and metabolites concentration in human vitreous
Time frame: 14 days
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.
1 secondary outcome
Citicoline and metabolites concentration in phakic and pseudophakic eyes
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Oddone, MD, PHD principal investigator
Fondazione G.B. Bietti, IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline in people with Neurodegenerative Diseases, run by Istituto di Ricerca Neuroftalmologia S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citicoline and metabolites concentration in human vitreous (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.