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

December 5, 2025 updated by: Pharmasoft

Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
    • Russian Federation
      • Tyumen, Russian Federation, Russia, 625026
        • Tyumen Scientific Center of the Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control (standard therapy)
IOP normalizing therapy
Active Comparator: Main (Mexidol and standard therapy)
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
Drug: Mexidol
Neurocytoprotector
Other Names:
  • Ethylmethylhydroxypyridine Succinate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)]
90 days
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)
90 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 90 days
Adverse events related to Mexidol
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmasoft

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Actual)

November 29, 2023

Study Completion (Actual)

February 2, 2024

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MexidolPOAG2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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