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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Glaucoma

Intervention / Treatment
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* Dietary Supplement: Citicoline 500 mg plus Homotaurine 50 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pattern electroretinogram, visual field, quality of life, citicoline 500 mg plus homotaurine 50 mg