Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electr… (NCT06431113) | Clinical Trial Compass
CompletedPhase 3
Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma
Italy40 participantsStarted 2024-01-27
Plain-language 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 learn about the safety of this fixed combination. The main questions it aims to answer are:
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* 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
Exclusion Criteria:
* 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
* topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination
* systemic or top…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 4 months
2
To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on PERG latencies
Timeframe: 4 months
Trial details
NCT IDNCT06431113
SponsorFondazione IRCCS Policlinico San Matteo di Pavia