GlaucomaNCT04422743
Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma
A study testing Citicoline 500 mg plus Homotaurine 50 mg in people with Glaucoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 4 sites in Italy.
Trial summary
the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Citicoline 500 mg plus Homotaurine 50 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesItaly
- Study dates
- 25 Jan 2018to 11 Sep 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 40 and 75 years;
- diagnosis of primary OAG (POAG) from, at least, 3 years;
- visual acuity > 0.7 (7/10) decimals;
- refractive error < 5 D (spheric) and < 2D (toric);
- transparent diopter means (cornea and lens);
- controlled IOP (<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed);
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- stable IOP<18 mmHg in the last 2 years;
- stable and unchanged topical therapy in the last 6 months;
- stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);
- at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years;
- early to moderate visual field defect (MD <12 dB);
- electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;
- written consent to participate to study procedures and data utilization in an anonymous form
Who cannot join
- ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
- congenital glaucoma; secondary glaucoma; normal tension glaucoma;
- history of recurrent uveitis/scleritis/herpes infection;
- pregnancy and breastfeeding;
- contraindication to Citicoline and/or Homotaurine
- contraindication to beta-blockers and prostaglandine analogues
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- topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide)
- topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment
- systemic therapies affecting patients' performance in visual field examination (sedatives);
- glaucomatous scotomas within 10 degree from fixation
- any condition limiting the patient's ability to participate in the study;
- other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;
- other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;
- cerebral ischemia in the last 2 years
- any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial
- any previous filtering and/or retinal surgery;
- cataract surgery in the last 6 months;
- any previous laser treatment for glaucoma in the last 5 years
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Dario Sisto
Bari, bari, 70121
Alberto Mavilio
Brindisi, 72100
Gemma Caterina Maria Rossi
Pavia, PV, 27100
Teresa Rolle
Torino, 10121
About this study
Official title: Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study
the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
Read the detailed description
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)
- Conditions
- Glaucoma
- Being tested
- Citicoline 500 mg plus Homotaurine 50 mg
- Keywords
- Pattern electroretinogram, visual field, quality of life, citicoline 500 mg plus homotaurine 50 mg
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline 500 mg plus Homotaurine 50 mgDietary supplement
Also called CIT/HOMO, Neuprozin®
Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
| Study group | Role | What they receive |
|---|---|---|
| standard of care + citicoline plus homotaurine (CIT/HOMO) | Experimental | CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication) Receives: Dietary Supplement: Citicoline 500 mg plus Homotaurine 50 mg |
| standard of care | No intervention | only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
changes in amplitude (microVolt)
Measured: 4 months of therapy 2 months of wash out 4 months without adding therapy
Secondary outcomes (3)
To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
changes in visual acuity (decimals)
Measured: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
Measured: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)
Measured: 4 months of therapy 2 months of wash out 4 months without adding therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 Jan 2018
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Why it stopped: due to covid 19 pandemy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Caterina Maria Rossi, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- gemma caterina m Rossi, Study director, IRCCS Fondazione Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422743
- Sponsor's protocol ID
- NP2017
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be published on peer review journal
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT04422743
- Acronym / sponsor ID
- NP2017
- Conditions
- Glaucoma
- Keywords
- Pattern electroretinogram, visual field, quality of life, citicoline 500 mg plus homotaurine 50 mg
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to covid 19 pandemy
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 9 Jun 2020 (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.
the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
Detailed description
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care + citicoline plus homotaurine (CIT/HOMO) | Experimental | Dietary Supplement: Citicoline 500 mg plus Homotaurine 50 mgCIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication) |
| standard of care | No intervention | –only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age between 40 and 75 years;
- diagnosis of primary OAG (POAG) from, at least, 3 years;
- visual acuity > 0.7 (7/10) decimals;
- refractive error < 5 D (spheric) and < 2D (toric);
- transparent diopter means (cornea and lens);
Key exclusion criteria (18 listed)
- ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
- congenital glaucoma; secondary glaucoma; normal tension glaucoma;
- history of recurrent uveitis/scleritis/herpes infection;
- pregnancy and breastfeeding;
- contraindication to Citicoline and/or Homotaurine
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 |
|---|---|---|
| Citicoline 500 mg plus Homotaurine 50 mgAlso: CIT/HOMO, Neuprozin®Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy | Dietary supplement | standard of care + citicoline plus homotaurine (CIT/HOMO) |
Primary outcome
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in amplitude (microVolt)
3 secondary outcomes
To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
Results and safety
The study was stopped early (reason given: due to covid 19 pandemy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. data will be published on peer review journal
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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.
gemma caterina m Rossi study director
IRCCS Fondazione Policlinico San Matteo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline 500 mg plus Homotaurine 50 mg in people with Glaucoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 4 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 13 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 was stopped early (reason given: due to covid 19 pandemy). Results are not available in the source record.
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?
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy (time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy). 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 May 2025.