NCT06431113CompletedPhase 3
Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma
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
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 21 May 2024
- Start date
- 27 Jan 2024
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Glaucoma
- NCT number
- NCT06431113
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 40
- From 27 Jan 2024 to the primary completion date, 1 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- topical therapy with Brimonidine or beta-blockers as monotherapy or fixed combination
- 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);
- 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
Other illness
- 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;
- 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;
Other
- pregnancy and breastfeeding;
- contraindication to Citicoline and/or Homotaurine and/or pyrroloquinoline quinone -PQQ
- contraindication to prostaglandine analogues
- systemic betablockers
- glaucomatous scotomas within 10 degree from fixation
- cerebral ischemia in the last 2 years
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Oculistica Università Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Gemma Caterina Maria Rossi Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.