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

Phase 4

Completed

• Conditions: Primary Open-Angle Glaucoma (POAG)
• Interventions: Drug: Mexidol

• Registration Number: NCT06437639
• Lead Sponsor: Pharmasoft

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2023-09-15
• Primary Completion: 2023-11-29
• Study Completion: 2024-02-02
• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Main (Mexidol and standard therapy)	Mexidol	Mexidol IV 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Degree of expression of mitochondrial dysfunction	90 days	Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
Dynamics of the structural and functional characteristics of mitochondria	90 days	Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)

Secondary Outcome Measures

Name	Time	Method
Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]	90 days	The average thickness of retinal nerve fibers (RNFL) of the peripapillary zone in four quadrants was studied using the Fast RNFL Thickness program and the thickness of the retinal ganglion cell complex (GCC-Ganglion Cell Complex protocol)
Аssessment of differential light sensitivity of the retina	90 days	Dynamics of index of mean deviation (MD) of retinal photosensitivity \[Static Automated Perimetry (SAP)\]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	90 days	Adverse events related to Mexidol

Trial Locations

Locations (1)

Tyumen Scientific Center of the Russian Academy of Sciences; 🇷🇺 Tyumen, Russian Federation