Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma (MEMO-GCAO)
Primary Purpose
Open-angle Glaucoma, Visual Field
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MEMOPTIC
usual treatment of glaucoma
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Citicoline, Gingko biloba, magnesium, Open-angle Glaucoma, visual field, MEMOPTIC
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MEMOPTIC added to the usual treatment of glaucoma
usual treatment of glaucoma
Arm Description
MEMOPTIC added to the usual treatment of glaucoma
usual treatment of glaucoma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04499157
First Posted
July 29, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04499157
Brief Title
Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
Acronym
MEMO-GCAO
Official Title
Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Visual Field
Keywords
Citicoline, Gingko biloba, magnesium, Open-angle Glaucoma, visual field, MEMOPTIC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MEMOPTIC added to the usual treatment of glaucoma
Arm Type
Experimental
Arm Description
MEMOPTIC added to the usual treatment of glaucoma
Arm Title
usual treatment of glaucoma
Arm Type
Active Comparator
Arm Description
usual treatment of glaucoma
Intervention Type
Drug
Intervention Name(s)
MEMOPTIC
Intervention Description
Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following
Intervention Type
Drug
Intervention Name(s)
usual treatment of glaucoma
Intervention Description
Patients will receive only their usual treatment of glaucoma.
Primary Outcome Measure Information:
Title
Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
Description
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.
Time Frame
from day 0 to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Iscar, MD
Phone
(33)322089200
Email
Iscar.claire@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Iscar, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
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