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Completed

NCT Number: NCT06437639

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

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.

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Key information

Conditions

Primary Open-Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Metabolic Diseases Mitochondrial Diseases Nutritional and Metabolic Diseases Ocular Hypertension

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tyumen Scientific Center of the Russian Academy of Sciences

Tyumen, Russian Federation, 625026, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mexidol

Drug

Neurocytoprotector

Other names: Ethylmethylhydroxypyridine Succinate

Primary outcomes

  1. Degree of expression of mitochondrial dysfunction

    Time frame: 90 days

    Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)

  2. Dynamics of the structural and functional characteristics of mitochondria

    Time frame: 90 days

    Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)

Secondary outcomes

  1. Аssessment of differential light sensitivity of the retina

    Time frame: 90 days

    Dynamics of index of mean deviation (MD) of retinal photosensitivity [Static Automated Perimetry (SAP)]

  2. Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]

    Time frame: 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)

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 90 days

    Adverse events related to Mexidol

Sponsors and collaborators

Lead sponsor

Pharmasoft

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 31, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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