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)
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2024
CompletedFirst Submitted
Initial submission to the registry
May 24, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedDecember 12, 2025
December 1, 2025
3 months
May 24, 2024
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Degree of expression of mitochondrial dysfunction
Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
90 days
Dynamics of the structural and functional characteristics of mitochondria
Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)
90 days
Secondary Outcomes (3)
Аssessment of differential light sensitivity of the retina
90 days
Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]
90 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
90 days
Study Arms (2)
Main (Mexidol and standard therapy)
ACTIVE COMPARATORMexidol 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
Control (standard therapy)
NO INTERVENTIONIOP normalizing therapy
Interventions
Neurocytoprotector
Eligibility Criteria
You may qualify if:
- An advanced stage of POAG in one or two eyes
- Hypotonic-compensated intraocular pressure (IOP)
You may not qualify if:
- 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
- Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmasoftlead
Study Sites (1)
Tyumen Scientific Center of the Russian Academy of Sciences
Tyumen, Russian Federation, 625026, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2024
First Posted
May 31, 2024
Study Start
September 15, 2023
Primary Completion
November 29, 2023
Study Completion
February 2, 2024
Last Updated
December 12, 2025
Record last verified: 2025-12