Primary Open-Angle Glaucoma (POAG)Phase 4NCT06437639
MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
A Phase 4 study testing Mexidol in people with Primary Open-Angle Glaucoma (POAG), run by Pharmasoft at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Primary Open-Angle Glaucoma (POAG)
- What is being tested?
- Mexidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2023to 2 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An advanced stage of POAG in one or two eyes
- Hypotonic-compensated intraocular pressure (IOP)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tyumen Scientific Center of the Russian Academy of Sciences
Tyumen, Russian Federation, 625026
About this study
Official 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)
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.
Read the 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
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Being tested
- Mexidol
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma (POAG), Glaucomatous Optic Neuropathy (GON), Mitochondrial Dysfunction, Neuroprotection, Mexidol, Ethylmethylhydroxypyridine Succinate
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexidolDrug
Also called Ethylmethylhydroxypyridine Succinate
Neurocytoprotector
| Study group | Role | What they receive |
|---|---|---|
| Main (Mexidol and standard therapy) | Active comparator | 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 Receives: Drug: Mexidol |
| Control (standard therapy) | No intervention | IOP normalizing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of expression of mitochondrial dysfunction
Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
Measured: 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)
Measured: 90 days
Secondary outcomes (3)
Аssessment of differential light sensitivity of the retina
Dynamics of index of mean deviation (MD) of retinal photosensitivity [Static Automated Perimetry (SAP)]
Measured: 90 days
Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]
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)
Measured: 90 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse events related to Mexidol
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Sep 2023
- Primary completion29 Nov 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437639
- Sponsor's protocol ID
- MexidolPOAG2024
- Status last verified
- Dec 2025
- First submitted
- 24 May 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06437639
- Acronym / sponsor ID
- MexidolPOAG2024
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma (POAG), Glaucomatous Optic Neuropathy (GON), Mitochondrial Dysfunction, Neuroprotection, Mexidol, Ethylmethylhydroxypyridine Succinate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PharmasoftIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main (Mexidol and standard therapy) | Active comparator | Drug: MexidolMexidol 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 intervention | –IOP normalizing therapy |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An advanced stage of POAG in one or two eyes
- Hypotonic-compensated intraocular pressure (IOP)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MexidolAlso: Ethylmethylhydroxypyridine SuccinateNeurocytoprotector | Drug | Main (Mexidol and standard therapy) |
Primary outcome
Degree of expression of mitochondrial dysfunction
Time frame: 90 days
Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
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)
3 secondary outcomes
Аssessment of differential light sensitivity of the retina
Time frame: 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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mexidol in people with Primary Open-Angle Glaucoma (POAG), run by Pharmasoft at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of expression of mitochondrial dysfunction (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.