Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma

NCT04422743 | Terminated

• 1 other identifier: NP2017
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Glaucoma

Keywords

Pattern electroretinogram; visual field; quality of life; citicoline 500 mg plus homotaurine 50 mg

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

  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

  4 months of therapy 2 months of wash out 4 months without adding therapy

Study Arms (2)

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)

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

Interventions

Citicoline 500 mg plus Homotaurine 50 mg DIETARY_SUPPLEMENT

Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy

Also known as: CIT/HOMO, Neuprozin®

standard of care + citicoline plus homotaurine (CIT/HOMO)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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

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
• contraindication to beta-blockers and prostaglandine analogues
• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (4)

Dario Sisto

Bari, bari, 70121, Italy

Location

Gemma Caterina Maria Rossi

Pavia, PV, 27100, Italy

Location

Alberto Mavilio

Brindisi, 72100, Italy

Location

Teresa Rolle

Torino, 10121, Italy

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Cytidine Diphosphate Choline; tramiprosate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye 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

Study Officials

• gemma caterina m Rossi

  IRCCS Fondazione Policlinico San Matteo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 25, 2018
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: May 1, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: upon publication
• Access Criteria: actually not available

Locations

IT (4)