Primary Open-Angle Glaucoma (POAG)Phase 2NCT06903156
Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma (POAG)
A Phase 2 study testing Mexidol in people with Primary Open-Angle Glaucoma (POAG), run by Pharmasoft at 7 sites in Russia.
Trial summary
The present trial is planned to investigate and identify the best dosage of investigational drugs with respect to the treatment of open-angle glaucoma. Therefore, multiple dose regimens of the investigational drug versus placebo drug are anticipated. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Primary Open-Angle Glaucoma (POAG)
- What is being tested?
- Mexidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 7 sitesRussia
- Study dates
- 15 Nov 2021to 7 Sep 2023
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged 35 to 75 years inclusive.
- Diagnosis of primary open-angle glaucoma stage II or III in both eyes.
- Intraocular pressure (IOP) compliance with ""target level"": tonometric IOP <21 mmHg in stage II, <19 mmHg in stage III, in both eyes.
- The patient's willingness and ability to fulfil the requirements of the protocol throughout the trial.
- Patients who signed informed consent to participate in the trial.
- For women with preserved reproductive potential, a negative pregnancy test and agreement to use adequate contraceptive methods throughout the trial.
- For men, agreement to adhere to adequate contraceptive methods for the duration of trial participation.
Who cannot join
- Individual intolerance or hypersensitivity to any of the components of the investigational medicinal products according to anamnesis data.
- Administration of nootropic, vasoactive drugs, neuroprotectants, antioxidants, metabolic drugs for 30 days prior to randomisation.
- The need to use medications that are prohibited in this trial.
- Primary open-angle glaucoma stage I or IV in at least one eye.
- Closed-angle glaucoma of at least one eye.
- The only eye.
Show all 41Show fewer
- Diagnosis of primary open-angle glaucoma stage II or III in one eye only.
- Visual acuity less than 0.1 (with correction) in at least one eye.
- Presence of an active infectious-inflammatory process in at least one eye.
- Low reliability of SAP results in at least one eye due to the patient's condition/disease: presence of 20% or more false positive and/or false negative errors, large amplitude and frequency of gaze direction deviations.
- The "mean deviation" (MD) score for static automatic perimetry (SAP) is -20 decibels or worse in at least one eye.
- Surgical and/or laser interventions on at least one eyeball within 3 months prior to inclusion in the trial.
- Significant opacities of the optical media in at least one eye, preventing assessment of the efficacy of therapy, including: severe scarring of the cornea, cataracts, consequences of uveitis.
- Retinal detachment in at least one eye.
- Thrombosis of a central retinal vein or artery in at least one eye.
- Myopia with a length of the anteroposterior axis of the eyeball greater than 26 mm in at least one eye.
- Diabetic retinopathy and other eye conditions that may affect the assessment of therapy efficacy.
- Presence of a history or finding of clinically significant pathology on screening, including but not limited to those listed below: unstable angina pectoris within 3 months before inclusion in the trial; myocardial infarction within 3 months prior to inclusion in the trial; acute heart failure; severe arrhythmia requiring treatment with class Ia, Ib, Ic or III antiarrhythmic drugs; decompensation of chronic heart failure (according to the New York Heart Association classification) within 3 months before inclusion in the trial; uncontrolled arterial hypertension with systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at screening; brain injury, stroke or transient ischaemic attack within 6 months prior to screening; occlusive blood vessel diseases; stenosing blood vessel diseases resulting in significant ischaemia of the relevant blood supply area; metabolic disorders, including severe renal insufficiency (creatinine clearance less than 30 ml/min); severe hepatic insufficiency (ALT or AST level is at least 2 times higher than the upper limit of normal values); malignant diseases of any localization with duration of remission less than 5 years according to anamnesis; II or III degree respiratory failure; community-acquired pneumonia within 6 months prior to inclusion in the trial; severe and/or uncontrolled endocrine and metabolic disorders requiring continuous medication; type 1 diabetes mellitus; type 2 diabetes mellitus, with a disease duration of 5 or more years; gastrointestinal disorders in the phase of relapse or exacerbation and requiring continuous medication.
- Positive serological reactions for infections at screening: Human immunodeficiency virus (antibodies to HIV-1/2); Hepatitis B (surface antigen); Hepatitis C (antibodies to hepatitis C virus antigens); Syphilis (antibodies to Treponema pallidum).
- Presence of other ophthalmological, neurological, otolaryngological or systemic diseases that may be the cause of optic nerve damage.
- The presence of any other pathology that, in the opinion of the investigator, is a contraindication to the patient's participation in the trial (i.e. may adversely affect the patient's condition if he or she participates in the trial), may interfere with the conduct of the trial procedures, or affect the ability to interpret the results of the trial. In case of doubt, the investigator should consult with the trial medical monitor.
- Signs of a first detected disease/pathology at screening.
- Positive rapid test for IgM antibodies to SARS-CoV-2 and/or positive SARS-CoV-2 RNA using nucleic acid amplification techniques
- Current or history (two years prior to screening) of alcoholism, drug abuse, drug dependence and/or substance abuse.
- Mental, physical and other reasons that make it impossible to adequately assess one's behaviour and correctly comply with the conditions of the trial protocol, including a history of mental illness.
- Lack of willingness to co-operate on the part of the patient.
- Pregnancy and breastfeeding period. A positive pregnancy test in women of childbearing potential.
- Patient participation in another clinical trial within the last 30 days.
- Patient refusal to continue participation in the trial.
- A decision by the Investigator or Sponsor to exclude a patient from the trial due to a significant protocol deviation/protocol violation.
- A serious adverse event (SAE) or an adverse event that does not meet the criteria for seriousness, for which, in the opinion of the Investigator, further participation in the trial may be detrimental to the health or well-being of the patient, or for which withdrawal of the investigational therapy is necessary.
- The need for procedures and/or adjunctive therapy not authorized by the protocol of this trial.
- Allergic reaction or individual intolerance to the investigational drugs, requiring their cancellation.
- Non-compliance with the therapy regime (patient's adherence to treatment with tablet form of the drug goes beyond 80%-120%, parenteral therapy - 100%), non-adherence (loss of contact with the patient with subsequent non-appearance at the visit, violation of visit dates, etc.).
- Need for modification of topical hypotensive therapy.
- Occurrence during the trial of conditions/diseases specified in the inclusion criteria.
- Any patient condition that, in the reasonable judgement of the investigator, requires the patient to be excluded from the trial.
- Erroneous inclusion.
- Positive pregnancy test in a trial participant.
- Positive rapid test for IgM antibodies to SARS-CoV-2 and/or positive SARS-CoV-2 RNA using nucleic acid amplification techniques.
- Erroneous unblinding of trial subject's treatment group.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Kirov Regional State Budgetary Healthcare Institution "Kirov Clinical Ophthalmological Hospital"
Kirov, 610047
Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental Institute named after A.I. Evdokimov" of the Ministry of Health of the RF
Moscow, 127473
Federal State Autonomous Institution "Intersectoral Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Health of the RF
Moscow, 127486
Budgetary healthcare institution of the Omsk region "V.P. Vyhodtsev Clinical Ophthalmological Hospital"
Omsk, 644024
Saint Petersburg State Budgetary Healthcare Institution "State Hospital No. 40 of the Kurortny District"
Saint Petersburg, 197706
Private healthcare institution "Clinical hospital "RZhD-Medicine" of the city of Saratov"
Saratov, 410004
State Budgetary Institution of Healthcare of the Yaroslavl Region "Clinical Hospital No. 2"
Yaroslavl, 150030
About this study
Official title: Prospective Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Trial of the Efficacy and Safety of Different Dosages in Sequential Therapy With Mexidol® in Patients With Primary Open-angle Glaucoma
The present trial is planned to investigate and identify the best dosage of investigational drugs with respect to the treatment of open-angle glaucoma. Therefore, multiple dose regimens of the investigational drug versus placebo drug are anticipated.
Read the detailed description
Glaucoma is a widespread group of diseases, which are united by disorders of the hydrodynamics of the eye with increased intraocular pressure (IOP), development of glaucoma optic neuropathy (GON) and corresponding irreversible changes in the optic nerve and visual fields.
The number of glaucoma patients worldwide ranges from 60.5 to 105 million, more than 1 million glaucoma patients have been identified in Russia, but it is assumed that the true number of patients is twice as high. According to epidemiological analysis, primary open-angle glaucoma (POAG) is the most common glaucoma worldwide, accounting for 75% to 90% of all primary glaucoma.
The active substance of Mexidol (ethylmethylhydroxypyridine succinate) has a multitarget effect on a number of links in the pathogenesis of POAG and is characterised by a high degree of safety, which corresponds to the concept of multimodal and modulating therapy of GON in POAG.
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Being tested
- Mexidol, Placebo
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma (POAG), Glaucomatous Optic Neuropathy (GON), Mitochondrial Dysfunction, Neuroprotection, Retiniprotection, 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
Neuroretinoprotector
PlaceboOther
Placebo therapy
| Study group | Role | What they receive |
|---|---|---|
| Mexidol High | Active comparator | High dose of Mexidol (Mexidol IV 500 mg 1 time a day for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 90 days) and standard therapy Receives: Drug: Mexidol |
| Mexidol Low | Active comparator | Low dose of Mexidol (Mexidol IV 100 mg 1 time a day for 14 days, then Mexidol 125 mg 1 tablet 3 times a day for 90 days) and standard therapy Receives: Drug: Mexidol |
| Placebo | Placebo comparator | Placebo and standard therapy according to a scheme similar to Mexidol groups Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in mean deviation (MD) in static automated perimetry (SAP) at the end of the course of therapy vs. baseline
Measured: Day 104
Secondary outcomes (9)
Mean change in the mean deviation (MD) of static automated perimetry (SAP) 14, 45 and 75 days from the start of therapy vs. baseline
Measured: 14, 45 and 75 days
Mean change in pattern standard deviation (PSD) at static automated perimetry (SAP) 14, 45, 75 and 104 days from the start of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Change in the number of relative scotomas (first and second order), number of absolute scotomas after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Mean change in visual acuity according to visometry without correction after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Mean change in visual acuity according to visometry with correction after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Mean change in the value of the threshold of electrical sensitivity of the optic nerve after 14, 45, 75 and 104 days from the beginning of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Mean change in the value of the electrical lability of the optic nerve after 14, 45, 75 and 104 days from the start of therapy vs. baseline level
Measured: 14, 45, 75 and 104 days
Dynamics of changes severity according to optical coherence tomography data after 14, 45, 75 and 104 days from the beginning of therapy in comparison with the initial level
Measured: 14, 45, 75 and 104 days
Dynamics of the severity of changes according to Heidelberg retinal tomography data after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Measured: 14, 45, 75 and 104 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start15 Nov 2021
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903156
- Sponsor's protocol ID
- MexidolPOAG2023
- Other IDs
- PHS-FOG-006-MEX-SOL-TAB
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2025
- 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 Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Trial of the Efficacy and Safety of Different Dosages in Sequential Therapy With Mexidol® in Patients With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT06903156
- Acronym / sponsor ID
- MexidolPOAG2023
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma (POAG), Glaucomatous Optic Neuropathy (GON), Mitochondrial Dysfunction, Neuroprotection, Retiniprotection, Mexidol, Ethylmethylhydroxypyridine Succinate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PharmasoftIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 30 Mar 2025 (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.
The present trial is planned to investigate and identify the best dosage of investigational drugs with respect to the treatment of open-angle glaucoma. Therefore, multiple dose regimens of the investigational drug versus placebo drug are anticipated.
Detailed description
Glaucoma is a widespread group of diseases, which are united by disorders of the hydrodynamics of the eye with increased intraocular pressure (IOP), development of glaucoma optic neuropathy (GON) and corresponding irreversible changes in the optic nerve and visual fields.
The number of glaucoma patients worldwide ranges from 60.5 to 105 million, more than 1 million glaucoma patients have been identified in Russia, but it is assumed that the true number of patients is twice as high. According to epidemiological analysis, primary open-angle glaucoma (POAG) is the most common glaucoma worldwide, accounting for 75% to 90% of all primary glaucoma.
The active substance of Mexidol (ethylmethylhydroxypyridine succinate) has a multitarget effect on a number of links in the pathogenesis of POAG and is characterised by a high degree of safety, which corresponds to the concept of multimodal and modulating therapy of GON in POAG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mexidol High | Active comparator | Drug: MexidolHigh dose of Mexidol (Mexidol IV 500 mg 1 time a day for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 90 days) and standard therapy |
| Mexidol Low | Active comparator | Drug: MexidolLow dose of Mexidol (Mexidol IV 100 mg 1 time a day for 14 days, then Mexidol 125 mg 1 tablet 3 times a day for 90 days) and standard therapy |
| Placebo | Placebo comparator | Other: PlaceboPlacebo and standard therapy according to a scheme similar to Mexidol groups |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes aged 35 to 75 years inclusive.
- Diagnosis of primary open-angle glaucoma stage II or III in both eyes.
- Intraocular pressure (IOP) compliance with ""target level"": tonometric IOP <21 mmHg in stage II, <19 mmHg in stage III, in both eyes.
- The patient's willingness and ability to fulfil the requirements of the protocol throughout the trial.
- Patients who signed informed consent to participate in the trial.
Key exclusion criteria (41 listed)
- Individual intolerance or hypersensitivity to any of the components of the investigational medicinal products according to anamnesis data.
- Administration of nootropic, vasoactive drugs, neuroprotectants, antioxidants, metabolic drugs for 30 days prior to randomisation.
- The need to use medications that are prohibited in this trial.
- Primary open-angle glaucoma stage I or IV in at least one eye.
- Closed-angle glaucoma of at least one eye.
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 SuccinateNeuroretinoprotector | Drug | Mexidol High, Mexidol Low |
| PlaceboPlacebo therapy | Other | Placebo |
Primary outcome
Mean change in mean deviation (MD) in static automated perimetry (SAP) at the end of the course of therapy vs. baseline
Time frame: Day 104
9 secondary outcomes
Mean change in the mean deviation (MD) of static automated perimetry (SAP) 14, 45 and 75 days from the start of therapy vs. baseline
Time frame: 14, 45 and 75 days
Mean change in pattern standard deviation (PSD) at static automated perimetry (SAP) 14, 45, 75 and 104 days from the start of therapy vs. baseline
Time frame: 14, 45, 75 and 104 days
Change in the number of relative scotomas (first and second order), number of absolute scotomas after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Time frame: 14, 45, 75 and 104 days
Mean change in visual acuity according to visometry without correction after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Time frame: 14, 45, 75 and 104 days
Mean change in visual acuity according to visometry with correction after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Time frame: 14, 45, 75 and 104 days
Mean change in the value of the threshold of electrical sensitivity of the optic nerve after 14, 45, 75 and 104 days from the beginning of therapy vs. baseline
Time frame: 14, 45, 75 and 104 days
Mean change in the value of the electrical lability of the optic nerve after 14, 45, 75 and 104 days from the start of therapy vs. baseline level
Time frame: 14, 45, 75 and 104 days
Dynamics of changes severity according to optical coherence tomography data after 14, 45, 75 and 104 days from the beginning of therapy in comparison with the initial level
Time frame: 14, 45, 75 and 104 days
Dynamics of the severity of changes according to Heidelberg retinal tomography data after 14, 45, 75 and 104 days from the start of therapy vs. baseline
Time frame: 14, 45, 75 and 104 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mexidol in people with Primary Open-Angle Glaucoma (POAG), run by Pharmasoft at 7 sites 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 7 inclusion and 41 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 7 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change in mean deviation (MD) in static automated perimetry (SAP) at the end of the course of therapy vs. baseline (time frame: Day 104). 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.