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

Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Dietary supplement: Citicoline 500 mg plus Homotaurine 50 mg

Detailed Description

Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70121
    • Dario Sisto
  • Brindisi, Italy, 72100
    • Alberto Mavilio
  • Torino, Italy, 10121
    • Teresa Rolle
  • PV
    • Pavia, PV, Italy, 27100
      • Gemma Caterina Maria Rossi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard of care + citicoline plus homotaurine (CIT/HOMO); 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; Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy; Other Names: CIT/HOMO; Neuprozin®
No Intervention: standard of care; only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	changes in visual acuity (decimals)	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	changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters	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	changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)	4 months of therapy 2 months of wash out 4 months without adding therapy

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Study Director: gemma caterina m Rossi, Irccs Fondazione Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; visual field; Pattern electroretinogram; citicoline 500 mg plus homotaurine 50 mg
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; GABA Agents; Anticonvulsants; Nootropic Agents; GABA Agonists; Cytidine Diphosphate Choline; Tramiprosate
• Other Study ID Numbers: NP2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be published on peer review journal
• IPD Sharing Time Frame: upon publication
• IPD Sharing Access Criteria: actually not available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No