Primary Open Angle GlaucomaNCT05315206
Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution
A study testing Citicoline in people with Primary Open Angle Glaucoma, run by Fondazione G.B. Bietti, IRCCS at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Citicoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Jan 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- Cataract or maculopathy
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- 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
Show all 12Show fewer
- 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
- 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)
- Pregnancy, breastfeeding
- Diabetes
- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
- Concomitant use of anticoagulants and lithium
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione BIetti, Britannico Hospital
Roma, 00184
Fondazione G.B. Bietti-IRCCS
Rome, 00199
About this study
Official title: Modulation of Neuronal Connettivity Along the Visual Pathways in Patients Affected by Glaucoma Throug Treatment With Citicoline Oral Solution: Multimodal Morpho-funcional Study
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:
Read more
- 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)
- 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).
Read the detailed description
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will be enrolled in the study within a maximum time frame of 12 months. The enrollment will be performed at T0 (screening), in this occasion an extensive ophthalmological evaluation will be performed after the signature of the informed consent. The patient will be undergoing to the evaluation of Best corrected Visual Acuity (BCVA), intraocular pressure (IOP), fundus examination, Visual Field (VF) exam (Humphrey 24-2and 10-2 standard SITA) Visual Evoked Potentials (VEP) and pattern electroretinogram (PERG). Moreover a morphological examination of optic nerve and macular area was assessed by Optical Coherence Tomography (OCT) with the analysis of retinal nerve fiber layer (RNFL) and retinal ganglion cells (RGCs).
Patients included in the study present a Mean Deviation defect (MD), tested at the VF examination, between -6 and -25 dB and an increase in Retinal-Cortical Time (RCT) response. RCT is a measure derived through the difference of Implicit Time values of latency of simultaneous recording of visual evoked potential (VEP) and pattern electroretinogram (PERG), which represent a post-retinal nerve conduction delay.
About 7-15 days after T0 a new ophthalmological examination will be performed (T1). The patient will be undergoing to the evaluation of BCVA, IOP, fundus examination, VF exam (Humphrey 24-2and 10-2 standard SITA), VEP, PERG and OCT. In this occasion a Magnetic Resonance Imaging (MRI) of the brain will be performed.
At the end of this evaluation, the patient will be given 4 bottles containing 500 ml of Citicoline in oral solution (Neurotidine®) or Placebo and will be given the relative instructions for administration. The posology will be 10 ml once a day in the morning for 6 months. At the end of the 6 month period the patient will be asked to hand over the used bottles.
After 6 months ± 10 days, a novel complete ophthalmologic evaluation will be performed (T2) (BCVA, IOP, VF exam, VEP, PERG, OCT), and patients will be given an additional 4 bottles containing Neurotidine ® or Placebo and will be given instructions for their administration. Again at the end of this 6 month period the patient will bring back the used bottles.
One year after T0, a last complete ophthalmological visit (BCVA, IOP, VF exam, VEP, PERG, OCT) will be performed (T3). In this visit MRI will be repeated. At the end of the visit, the patient will bring back the used bottles. Will be asked to the patient if adverse events will occurs during such period.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Citicoline, Placebo
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDietary supplement
The patient will be given 10 ml of Citicoline oral solution (Neurotidine ®) once a day in the morning for 1 year. To patients will be given 4 bottles containing 500 ml of Citicoline and the relative instructions for administration. After 6 months, the patient will bring back the used bottles and will be given additional 4 bottles containing Citicoline (Neurotidine ®). Again at the end of this 6 month period the patient will bring back the used bottles.
Each bottle of Neurotidine will contain: water; fructose; Citicoline (500 mg per 10 ml); acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavine.
PlaceboDietary supplement
The patient will be given 10 ml of an oral solution of Placebo. Each bottle of Placebo, the solution of which will be indistinguishable from the active product in terms of appearance and flavor, will contain: water; fructose; acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavin
| Study group | Role | What they receive |
|---|---|---|
| Citicoline Treated Group, TC Group | Experimental | In a group of patients with open angle glaucoma (OAG), Citicoline in oral solution (10 ml / day) will be administered for 12 months (Citicoline Treated Group, TC Group) Receives: Dietary Supplement: Citicoline |
| Placebo Treated Group, TP Group | Placebo comparator | in another group of patients with open angle glaucoma (OAG) will be administered Placebo (Containing all excipients of Citicoline in oral solution) (10 ml / day) for 12 months (Placebo Treated Group, TP Group) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retino-cortical time (RCT) changes after treatment with citicoline in oral solution.
The changes of the retino-cortical time (RCT) in patients affected by open angle glaucoma after one years of treatment with Citicoline in oral solution compared to patients affected by open angle glaucoma treated with placebo.
Measured: One year
Secondary outcomes (1)
Correlation between RCT changes and morpho-functional parameters changes after treatment with citicoline in oral solution.
In patients with open angle glaucoma, the changes of retino-cortical time (RCT) are associated or not with morphological and functional changes in the nerve structures that form the optical pathways, measured by OCT (RNFL and RGCs), visual field (MD) and magnetic resonance, after one year of treatment with Citicoline in oral solution respect to patients treated with Placebo.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start25 Jan 2022
- Primary completion31 Dec 2023
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 open angle glaucoma (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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vincenzo Parisi, Fondazione G.B. Bietti, IRCCS
- Investigators
- Vincenzo VP Parisi, MD, Principal investigator, IRCSS Fondazione Bietti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315206
- Sponsor's protocol ID
- 128/21/FB
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Quigley HA, McKinnon SJ, Zack DJ, Pease ME, Kerrigan-Baumrind LA, Kerrigan DF, Mitchell RS. Retrograde axonal transport of BDNF in retinal ganglion cells is blocked by acute IOP elevation in rats. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3460-6.
PubMed 11006239Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994 Mar 3;330(9):613-22. doi: 10.1056/NEJM199403033300907. No abstract available.
PubMed 7905600Oddone F, Lucenteforte E, Michelessi M, Rizzo S, Donati S, Parravano M, Virgili G. Macular versus Retinal Nerve Fiber Layer Parameters for Diagnosing Manifest Glaucoma: A Systematic Review of Diagnostic Accuracy Studies. Ophthalmology. 2016 May;123(5):939-49. doi: 10.1016/j.ophtha.2015.12.041. Epub 2016 Feb 15.
PubMed 26891880Parisi V. Impaired visual function in glaucoma. Clin Neurophysiol. 2001 Feb;112(2):351-8. doi: 10.1016/s1388-2457(00)00525-3.
PubMed 11165541Burgoyne CF, Downs JC, Bellezza AJ, Suh JK, Hart RT. The optic nerve head as a biomechanical structure: a new paradigm for understanding the role of IOP-related stress and strain in the pathophysiology of glaucomatous optic nerve head damage. Prog Retin Eye Res. 2005 Jan;24(1):39-73. doi: 10.1016/j.preteyeres.2004.06.001.
PubMed 15555526Furlanetto RL, Teixeira SH, Gracitelli CPB, Lottenberg CL, Emori F, Michelan M, Amaro E Jr, Paranhos A Jr. Structural and functional analyses of the optic nerve and lateral geniculate nucleus in glaucoma. PLoS One. 2018 Mar 23;13(3):e0194038. doi: 10.1371/journal.pone.0194038. eCollection 2018.
PubMed 29570721Schmidt MA, Knott M, Heidemann R, Michelson G, Kober T, Dorfler A, Engelhorn T. Investigation of lateral geniculate nucleus volume and diffusion tensor imaging in patients with normal tension glaucoma using 7 tesla magnetic resonance imaging. PLoS One. 2018 Jun 7;13(6):e0198830. doi: 10.1371/journal.pone.0198830. eCollection 2018.
PubMed 29879191Aksoy DO, Umurhan Akkan JC, Alkan A, Aralasmak A, Otcu Temur H, Yurtsever I. Magnetic Resonance Spectroscopy Features of the Visual Pathways in Patients with Glaucoma. Clin Neuroradiol. 2019 Dec;29(4):615-621. doi: 10.1007/s00062-018-0728-7. Epub 2018 Oct 5.
PubMed 30291364Wang Y, Wang X, Zhou J, Qiu J, Yan T, Xie Y, Li L, Lu W. Brain morphological alterations of cerebral cortex and subcortical nuclei in high-tension glaucoma brain and its associations with intraocular pressure. Neuroradiology. 2020 Apr;62(4):495-502. doi: 10.1007/s00234-019-02347-1. Epub 2019 Dec 23.
PubMed 31872278Gracitelli CPB, Duque-Chica GL, Sanches LG, Moura AL, Nagy BV, Teixeira SH, Amaro E Jr, Ventura DF, Paranhos A Jr. Structural Analysis of Glaucoma Brain and its Association With Ocular Parameters. J Glaucoma. 2020 May;29(5):393-400. doi: 10.1097/IJG.0000000000001470.
PubMed 32079996Parisi V, Manni G, Colacino G, Bucci MG. Cytidine-5'-diphosphocholine (citicoline) improves retinal and cortical responses in patients with glaucoma. Ophthalmology. 1999 Jun;106(6):1126-34. doi: 10.1016/S0161-6420(99)90269-5.
PubMed 10366081Parisi V, Centofanti M, Ziccardi L, Tanga L, Michelessi M, Roberti G, Manni G. Treatment with citicoline eye drops enhances retinal function and neural conduction along the visual pathways in open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2015 Aug;253(8):1327-40. doi: 10.1007/s00417-015-3044-9. Epub 2015 May 26.
PubMed 26004075Parisi V. Electrophysiological assessment of glaucomatous visual dysfunction during treatment with cytidine-5'-diphosphocholine (citicoline): a study of 8 years of follow-up. Doc Ophthalmol. 2005 Jan;110(1):91-102. doi: 10.1007/s10633-005-7348-7.
PubMed 16249960Parisi V, Coppola G, Centofanti M, Oddone F, Angrisani AM, Ziccardi L, Ricci B, Quaranta L, Manni G. Evidence of the neuroprotective role of citicoline in glaucoma patients. Prog Brain Res. 2008;173:541-54. doi: 10.1016/S0079-6123(08)01137-0.
PubMed 18929133Parisi V, Barbano L, Di Renzo A, Coppola G, Ziccardi L. Neuroenhancement and neuroprotection by oral solution citicoline in non-arteritic ischemic optic neuropathy as a model of neurodegeneration: A randomized pilot study. PLoS One. 2019 Jul 26;14(7):e0220435. doi: 10.1371/journal.pone.0220435. eCollection 2019.
PubMed 31348806
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Neuronal Connettivity Along the Visual Pathways in Patients Affected by Glaucoma Throug Treatment With Citicoline Oral Solution: Multimodal Morpho-funcional Study
- ClinicalTrials.gov ID
- NCT05315206
- Acronym / sponsor ID
- 128/21/FB
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Apr 2022 (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.
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:
- 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)
- 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).
Detailed description
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will be enrolled in the study within a maximum time frame of 12 months. The enrollment will be performed at T0 (screening), in this occasion an extensive ophthalmological evaluation will be performed after the signature of the informed consent. The patient will be undergoing to the evaluation of Best corrected Visual Acuity (BCVA), intraocular pressure (IOP), fundus examination, Visual Field (VF) exam (Humphrey 24-2and 10-2 standard SITA) Visual Evoked Potentials (VEP) and pattern electroretinogram (PERG). Moreover a morphological examination of optic nerve and macular area was assessed by Optical Coherence Tomography (OCT) with the analysis of retinal nerve fiber layer (RNFL) and retinal ganglion cells (RGCs).
Patients included in the study present a Mean Deviation defect (MD), tested at the VF examination, between -6 and -25 dB and an increase in Retinal-Cortical Time (RCT) response. RCT is a measure derived through the difference of Implicit Time values of latency of simultaneous recording of visual evoked potential (VEP) and pattern electroretinogram (PERG), which represent a post-retinal nerve conduction delay.
About 7-15 days after T0 a new ophthalmological examination will be performed (T1). The patient will be undergoing to the evaluation of BCVA, IOP, fundus examination, VF exam (Humphrey 24-2and 10-2 standard SITA), VEP, PERG and OCT. In this occasion a Magnetic Resonance Imaging (MRI) of the brain will be performed.
At the end of this evaluation, the patient will be given 4 bottles containing 500 ml of Citicoline in oral solution (Neurotidine®) or Placebo and will be given the relative instructions for administration. The posology will be 10 ml once a day in the morning for 6 months. At the end of the 6 month period the patient will be asked to hand over the used bottles.
After 6 months ± 10 days, a novel complete ophthalmologic evaluation will be performed (T2) (BCVA, IOP, VF exam, VEP, PERG, OCT), and patients will be given an additional 4 bottles containing Neurotidine ® or Placebo and will be given instructions for their administration. Again at the end of this 6 month period the patient will bring back the used bottles.
One year after T0, a last complete ophthalmological visit (BCVA, IOP, VF exam, VEP, PERG, OCT) will be performed (T3). In this visit MRI will be repeated. At the end of the visit, the patient will bring back the used bottles. Will be asked to the patient if adverse events will occurs during such period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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 open angle glaucoma (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)
| Arm | Type | Receives |
|---|---|---|
| Citicoline Treated Group, TC Group | Experimental | Dietary Supplement: CiticolineIn a group of patients with open angle glaucoma (OAG), Citicoline in oral solution (10 ml / day) will be administered for 12 months (Citicoline Treated Group, TC Group) |
| Placebo Treated Group, TP Group | Placebo comparator | Dietary Supplement: Placeboin another group of patients with open angle glaucoma (OAG) will be administered Placebo (Containing all excipients of Citicoline in oral solution) (10 ml / day) for 12 months (Placebo Treated Group, TP Group) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- Cataract or maculopathy
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- Known hypersensitivity to the study product
- Secondary causes of ocular hypertension, including systemic or topical use of steroids
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 |
|---|---|---|
| CiticolineThe patient will be given 10 ml of Citicoline oral solution (Neurotidine ®) once a day in the morning for 1 year. To patients will be given 4 bottles containing 500 ml of Citicoline and the relative instructions for administration. After 6 months, the patient will bring back the used bottles and will be given additional 4 bottles containing Citicoline (Neurotidine ®). Again at the end of this 6 month period the patient will bring back the used bottles. Each bottle of Neurotidine will contain: water; fructose; Citicoline (500 mg per 10 ml); acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavine. | Dietary supplement | Citicoline Treated Group, TC Group |
| PlaceboThe patient will be given 10 ml of an oral solution of Placebo. Each bottle of Placebo, the solution of which will be indistinguishable from the active product in terms of appearance and flavor, will contain: water; fructose; acidity regulators: sodium citrate, sodium hydroxide; preservative: potassium sorbate; dye: riboflavin | Dietary supplement | Placebo Treated Group, TP Group |
Primary outcome
Retino-cortical time (RCT) changes after treatment with citicoline in oral solution.
Time frame: One year
The changes of the retino-cortical time (RCT) in patients affected by open angle glaucoma after one years of treatment with Citicoline in oral solution compared to patients affected by open angle glaucoma treated with placebo.
1 secondary outcome
Correlation between RCT changes and morpho-functional parameters changes after treatment with citicoline in oral solution.
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Results publication: PubMed 11006239Quigley HA, McKinnon SJ, Zack DJ, Pease ME, Kerrigan-Baumrind LA, Kerrigan DF, Mitchell RS. Retrograde axonal transport of BDNF in retinal ganglion cells is blocked by acute IOP elevation in rats. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3460-6.
- Results publication: PubMed 7905600Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994 Mar 3;330(9):613-22. doi: 10.1056/NEJM199403033300907. No abstract available.
- Results publication: PubMed 26891880Oddone F, Lucenteforte E, Michelessi M, Rizzo S, Donati S, Parravano M, Virgili G. Macular versus Retinal Nerve Fiber Layer Parameters for Diagnosing Manifest Glaucoma: A Systematic Review of Diagnostic Accuracy Studies. Ophthalmology. 2016 May;123(5):939-49. doi: 10.1016/j.ophtha.2015.12.041. Epub 2016 Feb 15.
- Results publication: PubMed 11165541Parisi V. Impaired visual function in glaucoma. Clin Neurophysiol. 2001 Feb;112(2):351-8. doi: 10.1016/s1388-2457(00)00525-3.
- Results publication: PubMed 15555526Burgoyne CF, Downs JC, Bellezza AJ, Suh JK, Hart RT. The optic nerve head as a biomechanical structure: a new paradigm for understanding the role of IOP-related stress and strain in the pathophysiology of glaucomatous optic nerve head damage. Prog Retin Eye Res. 2005 Jan;24(1):39-73. doi: 10.1016/j.preteyeres.2004.06.001.
- Results publication: PubMed 29570721Furlanetto RL, Teixeira SH, Gracitelli CPB, Lottenberg CL, Emori F, Michelan M, Amaro E Jr, Paranhos A Jr. Structural and functional analyses of the optic nerve and lateral geniculate nucleus in glaucoma. PLoS One. 2018 Mar 23;13(3):e0194038. doi: 10.1371/journal.pone.0194038. eCollection 2018.
- Results publication: PubMed 29879191Schmidt MA, Knott M, Heidemann R, Michelson G, Kober T, Dorfler A, Engelhorn T. Investigation of lateral geniculate nucleus volume and diffusion tensor imaging in patients with normal tension glaucoma using 7 tesla magnetic resonance imaging. PLoS One. 2018 Jun 7;13(6):e0198830. doi: 10.1371/journal.pone.0198830. eCollection 2018.
- Results publication: PubMed 30291364Aksoy DO, Umurhan Akkan JC, Alkan A, Aralasmak A, Otcu Temur H, Yurtsever I. Magnetic Resonance Spectroscopy Features of the Visual Pathways in Patients with Glaucoma. Clin Neuroradiol. 2019 Dec;29(4):615-621. doi: 10.1007/s00062-018-0728-7. Epub 2018 Oct 5.
- Results publication: PubMed 31872278Wang Y, Wang X, Zhou J, Qiu J, Yan T, Xie Y, Li L, Lu W. Brain morphological alterations of cerebral cortex and subcortical nuclei in high-tension glaucoma brain and its associations with intraocular pressure. Neuroradiology. 2020 Apr;62(4):495-502. doi: 10.1007/s00234-019-02347-1. Epub 2019 Dec 23.
- Results publication: PubMed 32079996Gracitelli CPB, Duque-Chica GL, Sanches LG, Moura AL, Nagy BV, Teixeira SH, Amaro E Jr, Ventura DF, Paranhos A Jr. Structural Analysis of Glaucoma Brain and its Association With Ocular Parameters. J Glaucoma. 2020 May;29(5):393-400. doi: 10.1097/IJG.0000000000001470.
- Results publication: PubMed 10366081Parisi V, Manni G, Colacino G, Bucci MG. Cytidine-5'-diphosphocholine (citicoline) improves retinal and cortical responses in patients with glaucoma. Ophthalmology. 1999 Jun;106(6):1126-34. doi: 10.1016/S0161-6420(99)90269-5.
- Results publication: PubMed 26004075Parisi V, Centofanti M, Ziccardi L, Tanga L, Michelessi M, Roberti G, Manni G. Treatment with citicoline eye drops enhances retinal function and neural conduction along the visual pathways in open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2015 Aug;253(8):1327-40. doi: 10.1007/s00417-015-3044-9. Epub 2015 May 26.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Vincenzo VP Parisi, MD principal investigator
IRCSS Fondazione Bietti
2 sites 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 Primary Open Angle Glaucoma, run by Fondazione G.B. Bietti, IRCCS at 2 sites 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Retino-cortical time (RCT) changes after treatment with citicoline in oral solution. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315206, which also lists 22 linked publications.
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 26 Feb 2025.