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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04499157

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Visual Field	Drug: MEMOPTIC Drug: usual treatment of glaucoma	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: MEMOPTIC added to the usual treatment of glaucoma

MEMOPTIC added to the usual treatment of glaucoma

Drug: MEMOPTIC

Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following

Active Comparator: usual treatment of glaucoma

usual treatment of glaucoma

Drug: usual treatment of glaucoma

Patients will receive only their usual treatment of glaucoma.

Outcome Measures

Primary Outcome Measures

Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment [from day 0 to 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)