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

NCT06431113 | Completed Phase 3

• 1 other identifier: NP-MITO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Glaucoma; Neuroprotection

Keywords

glaucoma; neuroprotection; citicoline; homotaurine; Pyrroloquinoline quinone; visual field; pattern electroretinogram; oct; quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  4 months

Secondary Outcomes (5)

• To compare the two treatments in terms of: • visual acuity over time

  4 months

• To compare the two treatments in terms of: • visual field changes over time, if any

  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

  4 months

• To compare the two treatments in terms of: • optical coherence tomography - OCT changes over time, if any

  4 months

• To compare the two treatments in terms of: • Safety (Incidence of adverse events)

  8 months

Study Arms (2)

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

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

Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )

Interventions

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

Cebrolux -CIT for 4 months; Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Federico II University: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (2)

Clinica Oculistica Università Federico II

Napoli, Napoli, 80100, Italy

Location

Gemma Caterina Maria Rossi

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Glaucoma; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Cytidine Diphosphate Choline; tramiprosate; PQQ Cofactor

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ciro Costagliola, MD

  Federico II University eye Clinic, Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Ophthalmologist

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: January 27, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2024-05

Locations

IT (2)