GlaucomaPhase 3NCT06431113

Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma

A Phase 3 study testing Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) in people with Glaucoma and Neuroprotection, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to examine the effect of the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) on pattern electroretinogram (PERG) in patients with primary open angle glaucoma on well controlled intraocular pressure It will also… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Neuroprotection
What is being tested?: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesItaly
Study dates: 27 Jan 2024to 1 Mar 2025
Phase: Phase 3
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;
diagnosis of primary OAG (POAG) from, at least, 3 years;
visual acuity > 0.7 (7/10) decimals;
refractive error < 5 Diopter (D) (spheric) and < 2D (toric);
transparent diopter means (cornea and lens);
controlled intraocular pressure (IOP) (<18 mmHg, morning value) with prostaglandin analogues as monotherapy;

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stable intraocular pressure - IOP < 18 mmHg in the last 2 years;
stable and unchanged topical therapy in the last 6 months;
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 (mean deviation, MD <12 dB);
electrophysiological (pattern electroretinogram-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 and/or pyrroloquinoline quinone -PQQ
contraindication to prostaglandine analogues
topical therapy with Brimonidine or beta-blockers as monotherapy or fixed combination

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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 betablockers
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, acute lateral sclerosis, multiple sclerosis) 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

2 sites in 1 country.

Italy2 sites

Clinica Oculistica Università Federico II
Naples, Napoli, 80100
Gemma Caterina Maria Rossi
Pavia, PV, 27100

Other trials in Italy

About this study

Official title: Effect of Fixed Combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline Quinone (Neuprozin Mito®) on Pattern Electroretinogram in Controlled Open Angle Glaucoma Patients:A Multicenter, Randomized, Single Blind, Cross-over Study

Does the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) improve PERG amplitude and/or latency? Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology? Does the fixed combination improve quality of life of glaucoma patients? Does the fixed combination have any effect on optical coherence tomography (OCT)?

Researchers will compare the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma.

Participants will:

Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months.

Visit the clinic at enrollment and once every 4 months (at month 4 and at month 8) for checkups and tests (visual field, OCT, PERG and quality of life questionnaire)

Read the detailed description

Our general purpose is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.

Primary objective To compare the effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) a tablet a day on PERG examination (p50 wave) at four months of therapy, compared to citicoline 800 mg alone (Cebrolux® - CIT), as add-on to standard topical therapy.

Secondary objectives

To compare the two treatments (Neuprozin Mito® - NPM vs citicoline - CIT - alone) in terms of:

visual acuity over time
visual field changes over time, if any
Quality of Life perception (National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire) over time
optical coherence tomography - OCT- changes over time, if any
Safety (Incidence of adverse events)

Study design and planning Multicentric, randomized, 2-sequence, 2-period, 2-treatment, crossover study, with blind outcome assessor.

Centers

Azienda Ospedaliera Universitaria Federico II ; UOC Oculistica, Napoli
Clinica Oculistica dell'Università degli Studi di Pavia, IRCCS Policlinico San Matteo Foundation, Pavia.
Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale, Università di Roma "Sapienza", Roma

Study duration Study duration ; 14 months Enrolment period: 6 months Minimum Follow-up: 8 months Total sample size: 40 patients

Conditions: Glaucoma, Neuroprotection
Being tested: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )
Keywords: glaucoma, neuroprotection, citicoline, homotaurine, Pyrroloquinoline quinone, visual field, pattern electroretinogram, oct, quality of life
Medical subject headings: Glaucoma, Ornithine Carbamoyltransferase Deficiency Disease

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 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )Combination product
treatment for 4 months and then cross over to the other therapy

Study groups in NCT06431113
Study group	Role	What they receive
Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM)	Experimental	Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) fixed combination for 4 months followed by Cebrolux -CIT for 4 months, besides standard topical treatment Receives: Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )
Cebrolux -CIT for 4 months	Active comparator	Citicoline 800 (Cebrolux-CIT) for 4 months followed by Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) for 4 months, besides standard topical treatment Receives: Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on pattern-electroretinogram -PERG- amplitudes
amplitude of PERG waves (microVolt)
Measured: 4 months
To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on PERG latencies
latency of PERG waves (milliseconds)
Measured: 4 months

Secondary outcomes (5)

To compare the two treatments in terms of: • visual acuity over time
visual acuity evaluation
Measured: 4 months
To compare the two treatments in terms of: • visual field changes over time, if any
Pattern Standard Deviation and Mean Deviation (deciBell)
Measured: 4 months
To compare the two treatments in terms of: • Quality of Life perception national eye institute-visual function questionnaire 25 items (NEI VFQ25) over time
quality of life with questionnaire national eye institute-visual function questionnaire 25 items (NEI-VFQ25) (from 0=worst score/quality of life to 100 better score/quality of life)
Measured: 4 months
To compare the two treatments in terms of: • optical coherence tomography - OCT changes over time, if any
retinal nerve fiber layer (RNFL) and ganglion cells complex (GCC)
Measured: 4 months
To compare the two treatments in terms of: • Safety (Incidence of adverse events)
adverse events onset
Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 20241 Mar 2025

First posted28 May 2024
Study start27 Jan 2024
Primary completion1 Mar 2025
Study completion1 Mar 2025

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06431113
Sponsor's protocol ID: NP-MITO
Status last verified: May 2024
First submitted: 21 May 2024
Last updated: 1 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 Fixed Combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline Quinone (Neuprozin Mito®) on Pattern Electroretinogram in Controlled Open Angle Glaucoma Patients:A Multicenter, Randomized, Single Blind, Cross-over Study
ClinicalTrials.gov ID: NCT06431113
Acronym / sponsor ID: NP-MITO
Conditions: Glaucoma, Neuroprotection
Keywords: glaucoma, neuroprotection, citicoline, homotaurine, Pyrroloquinoline quinone, visual field, pattern electroretinogram, oct
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
Collaborators: Federico II University, University of Roma La Sapienza
Study start: 27 Jan 2024 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 28 May 2024 (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.

Participants will:

Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months.

Visit the clinic at enrollment and once every 4 months (at month 4 and at month 8) for checkups and tests (visual field, OCT, PERG and quality of life questionnaire)

Detailed description

Secondary objectives

To compare the two treatments (Neuprozin Mito® - NPM vs citicoline - CIT - alone) in terms of:

visual acuity over time
visual field changes over time, if any
Quality of Life perception (National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire) over time
optical coherence tomography - OCT- changes over time, if any
Safety (Incidence of adverse events)

Study design and planning Multicentric, randomized, 2-sequence, 2-period, 2-treatment, crossover study, with blind outcome assessor.

Centers

Azienda Ospedaliera Universitaria Federico II ; UOC Oculistica, Napoli
Clinica Oculistica dell'Università degli Studi di Pavia, IRCCS Policlinico San Matteo Foundation, Pavia.
Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale, Università di Roma "Sapienza", Roma

Study duration Study duration ; 14 months Enrolment period: 6 months Minimum Follow-up: 8 months Total sample size: 40 patients

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM)	Experimental	Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) fixed combination for 4 months followed by Cebrolux -CIT for 4 months, besides standard topical treatment
Cebrolux -CIT for 4 months	Active comparator	Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )Citicoline 800 (Cebrolux-CIT) for 4 months followed by Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) for 4 months, besides standard topical treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

age > 18 years;
diagnosis of primary OAG (POAG) from, at least, 3 years;
visual acuity > 0.7 (7/10) decimals;
refractive error < 5 Diopter (D) (spheric) and < 2D (toric);
transparent diopter means (cornea and lens);

Key exclusion criteria (20 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 and/or pyrroloquinoline quinone -PQQ
contraindication to prostaglandine analogues

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 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )treatment for 4 months and then cross over to the other therapy	Combination product	Cebrolux -CIT for 4 months, Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM)

Primary outcome

To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on pattern-electroretinogram -PERG- amplitudes
Time frame: 4 months
amplitude of PERG waves (microVolt)
To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on PERG latencies
Time frame: 4 months
latency of PERG waves (milliseconds)

5 secondary outcomes

To compare the two treatments in terms of: • visual acuity over time
Time frame: 4 months
To compare the two treatments in terms of: • visual field changes over time, if any
Time frame: 4 months
To compare the two treatments in terms of: • Quality of Life perception national eye institute-visual function questionnaire 25 items (NEI VFQ25) over time
Time frame: 4 months
To compare the two treatments in terms of: • optical coherence tomography - OCT changes over time, if any
Time frame: 4 months
To compare the two treatments in terms of: • Safety (Incidence of adverse events)
Time frame: 8 months

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 May 2025.

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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.

Ciro Costagliola, MD principal investigator

Federico II University eye Clinic, Naples

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 20 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 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on pattern-electroretinogram -PERG- amplitudes (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT06431113.

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.