NCT06903156

Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma (POAG)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Pharmasoft · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-Angle Glaucoma (POAG)

Interventions

Type	Name	Description
DRUG	Mexidol	Neuroretinoprotector
OTHER	Placebo	Placebo therapy

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2025-03-30
• Last updated: 2025-12-12

Locations

7 sites across 1 country: Russia