Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06903156
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma (POAG)
Sponsor:
Pharmasoft
Organization:
Study Overview
Official Title:
Prospective Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Trial of the Efficacy and Safety of Different Dosages in Sequential Therapy With Mexidol® in Patients With Primary Open-angle Glaucoma
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present trial is planned to investigate and identify the best dosage of investigational drugs with respect to the treatment of open-angle glaucoma. Therefore, multiple dose regimens of the investigational drug versus placebo drug are anticipated.
Detailed Description:
Glaucoma is a widespread group of diseases, which are united by disorders of the hydrodynamics of the eye with increased intraocular pressure (IOP), development of glaucoma optic neuropathy (GON) and corresponding irreversible changes in the optic nerve and visual fields.
The number of glaucoma patients worldwide ranges from 60.5 to 105 million, more than 1 million glaucoma patients have been identified in Russia, but it is assumed that the true number of patients is twice as high. According to epidemiological analysis, primary open-angle glaucoma (POAG) is the most common glaucoma worldwide, accounting for 75% to 90% of all primary glaucoma.
The active substance of Mexidol (ethylmethylhydroxypyridine succinate) has a multitarget effect on a number of links in the pathogenesis of POAG and is characterised by a high degree of safety, which corresponds to the concept of multimodal and modulating therapy of GON in POAG.
The number of glaucoma patients worldwide ranges from 60.5 to 105 million, more than 1 million glaucoma patients have been identified in Russia, but it is assumed that the true number of patients is twice as high. According to epidemiological analysis, primary open-angle glaucoma (POAG) is the most common glaucoma worldwide, accounting for 75% to 90% of all primary glaucoma.
The active substance of Mexidol (ethylmethylhydroxypyridine succinate) has a multitarget effect on a number of links in the pathogenesis of POAG and is characterised by a high degree of safety, which corresponds to the concept of multimodal and modulating therapy of GON in POAG.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHS-FOG-006-MEX-SOL-TAB | OTHER | Ministry of Health, Russian Federation | View |