Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma

Study Overview
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Brief Summary
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Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients. The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.

Official Title
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Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma

Conditions
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Open-angle Glaucoma, Visual Field

Intervention / Treatment
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* Drug: MEMOPTIC
* Drug: usual treatment of glaucoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects age between 20 and 80 years old Well controled intra-ocular pressure under treatment (PIO<21mmHg or decreased by 20% compared to initial the PIO) Exclusion Criteria: retinal or macular disease diagnosis of cataract or surgery of cataract during the follow-up allergy to citicolin ocular hypertonia due to a secondary cause (like corticosteroids) history of anterior, intermediate or posterior uveitis general treatment affecting PIO (beta blockers, corticosteroids) pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEMOPTIC added to the usual treatment of glaucoma<br>MEMOPTIC added to the usual treatment of glaucoma | Drug: MEMOPTIC<br>* Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following<br>|
| Active Comparator: usual treatment of glaucoma<br>usual treatment of glaucoma | Drug: usual treatment of glaucoma<br>* Patients will receive only their usual treatment of glaucoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment | Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment versus visual field of open angle-glaucoma patients without MEMOPTIC treatment. Visual field is measure with METROVISION Visual Field 24-2, a full field projection perimeter entirely compatible with the Goldmann standard and modern perimetry standard. It allows high resolution static perimetry as well as kinetic perimetry with automated and manual modes. Automated static perimetry is one of the methods used to screen and follow up patients who have glaucoma. It consists of approximately 100 quantitative threshold measures that permit evaluation of retinal sensitivity. Each measure is standardized in a population free of ocular disease, and two simple statistics are calculated: mean deviation (MD) and pattern standard deviation (PSD). These indices are widely used in glaucoma clinical trials and patient follow-up. | from day 0 to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citicoline, Gingko biloba, magnesium, Open-angle Glaucoma, visual field, MEMOPTIC