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

NCT ID: NCT06437639

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-02-02

Brief Summary

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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

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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

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Primary Open-Angle Glaucoma (POAG)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Main (Mexidol and standard therapy)

Mexidol IV 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks

Group Type ACTIVE_COMPARATOR

Mexidol

Intervention Type DRUG

Neurocytoprotector

Control (standard therapy)

IOP normalizing therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mexidol

Neurocytoprotector

Intervention Type DRUG

Other Intervention Names

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Ethylmethylhydroxypyridine Succinate

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmasoft

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tyumen Scientific Center of the Russian Academy of Sciences

Tyumen, Russian Federation, Russia

Site Status

Countries

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Russia

Other Identifiers

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MexidolPOAG2024

Identifier Type: -

Identifier Source: org_study_id