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

NCT ID: NCT04422743

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2020-09-11

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.

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)

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Citicoline 500 mg plus Homotaurine 50 mg

Intervention Type: DIETARY_SUPPLEMENT

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

standard of care

only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Citicoline 500 mg plus Homotaurine 50 mg

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CIT/HOMO; Neuprozin®

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Gemma Caterina Maria Rossi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gemma caterina m Rossi

Role: STUDY_DIRECTOR

IRCCS Fondazione Policlinico San Matteo

Locations

Dario Sisto

Bari, bari, Italy

Gemma Caterina Maria Rossi

Pavia, PV, Italy

Alberto Mavilio

Brindisi, , Italy

Teresa Rolle

Torino, , Italy

Countries

Italy

Other Identifiers

NP2017

Identifier Type: -

Identifier Source: org_study_id