NCT04499157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

July 29, 2020

Last Update Submit

February 7, 2023

Conditions

Open-angle GlaucomaVisual Field

Keywords

CiticolineGingko bilobamagnesiumOpen-angle Glaucomavisual fieldMEMOPTIC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MEMOPTIC added to the usual treatment of glaucoma

EXPERIMENTAL

MEMOPTIC added to the usual treatment of glaucoma

Drug: MEMOPTIC

usual treatment of glaucoma

ACTIVE COMPARATOR

usual treatment of glaucoma

Drug: usual treatment of glaucoma

Interventions

MEMOPTICDRUG

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

MEMOPTIC added to the usual treatment of glaucoma
usual treatment of glaucomaDRUG

Patients will receive only their usual treatment of glaucoma.

usual treatment of glaucoma

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Claire Iscar, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Iscar, MD

CONTACT

(33)322089200Iscar.claire@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 5, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)