Clinical trial

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

Name
PI2019_843_0061
Description
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 arms
Trial start
2020-08-01
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Recruiting
Treatment
MEMOPTIC
Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following
Arms:
MEMOPTIC added to the usual treatment of glaucoma
usual treatment of glaucoma
Patients will receive only their usual treatment of glaucoma.
Arms:
usual treatment of glaucoma
Size
100
Primary endpoint
Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
from day 0 to 2 years
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-02-08

1 organization

2 products

2 indications

Product
MEMOPTIC
Indication
Visual Field
Product
Glaucoma