MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)

Pharmasoft

Status and phase: Completed; Phase 4

Conditions: Primary Open-Angle Glaucoma (POAG)

Treatments: Drug: Mexidol

Study type: Interventional

Funder types: Industry

Identifiers

NCT06437639

MexidolPOAG2024

Details and patient eligibility

About

Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.

Full description

Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function

Enrollment: 80 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An advanced stage of POAG in one or two eyes
• Hypotonic-compensated intraocular pressure (IOP)

Exclusion criteria

• Degenerative diseases of the central nervous system, diabetes mellitus
• Primary mitochondrial dysfunction
• A history of surgical interventions and damage to the organ of vision
• Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections)
• Decompensation of concomitant somatic diseases
• Taking antioxidants/nootropic drugs 6 months before inclusion in the study
• Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Main (Mexidol and standard therapy)

Active Comparator group

Description:

Mexidol IM 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; IOP normalizing therapy

Treatment:

Drug: Mexidol

Control (standard therapy)

No Intervention group

Description:

IOP normalizing therapy