Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma (POAG)

NCT06903156 | Completed Phase 2

• 2 other identifiers: MexidolPOAG2023PHS-FOG-006-MEX-SOL-TAB
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Primary Open-Angle Glaucoma (POAG)

Keywords

Glaucoma; Primary Open-Angle Glaucoma (POAG); Glaucomatous Optic Neuropathy (GON); Mitochondrial Dysfunction; Neuroprotection; Retiniprotection; Mexidol; Ethylmethylhydroxypyridine Succinate

Outcome Measures

Primary Outcomes (1)

• Mean change in mean deviation (MD) in static automated perimetry (SAP) at the end of the course of therapy vs. baseline

  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

  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

  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

  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

  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

  14, 45, 75 and 104 days

Study Arms (3)

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

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

Drug: Mexidol

Placebo

PLACEBO COMPARATOR

Placebo and standard therapy according to a scheme similar to Mexidol groups

Other: Placebo

Interventions

Mexidol DRUG

Neuroretinoprotector

Also known as: Ethylmethylhydroxypyridine Succinate

Mexidol High; Mexidol Low

Placebo OTHER

Placebo therapy

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (7)

Kirov Regional State Budgetary Healthcare Institution "Kirov Clinical Ophthalmological Hospital"

Kirov, 610047, Russia

Location

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, Russia

Location

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, Russia

Location

Budgetary healthcare institution of the Omsk region "V.P. Vyhodtsev Clinical Ophthalmological Hospital"

Omsk, 644024, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "State Hospital No. 40 of the Kurortny District"

Saint Petersburg, 197706, Russia

Location

Private healthcare institution "Clinical hospital "RZhD-Medicine" of the city of Saratov"

Saratov, 410004, Russia

Location

State Budgetary Institution of Healthcare of the Yaroslavl Region "Clinical Hospital No. 2"

Yaroslavl, 150030, Russia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma; Mitochondrial Diseases

Interventions

emoxypine succinate; ethylmethylhydroxypyridine succinate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: November 15, 2021
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

RU (7)