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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

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

First Posted
July 29, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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

Learn more about this trial

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

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