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

Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06437639

Enrollment

Registered

2024-05-31

Start date

2023-09-15

Completion date

2024-02-02

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-Angle Glaucoma (POAG)

Keywords

Glaucoma, Primary Open-Angle Glaucoma (POAG), Glaucomatous Optic Neuropathy (GON), Mitochondrial Dysfunction, Neuroprotection, Mexidol, Ethylmethylhydroxypyridine Succinate

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

Interventions

DRUGMexidol

Neurocytoprotector

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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)
Degree of expression of mitochondrial dysfunction	90 days	Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)

Secondary

Measure	Time frame	Description
Аssessment of differential light sensitivity of the retina	90 days	Dynamics of index of mean deviation (MD) of retinal photosensitivity \[Static Automated Perimetry (SAP)\]
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)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	90 days	Adverse events related to Mexidol

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026