## Protocol Section
### Identification Module
**NCT ID:** NCT06437639

**Brief Title:** MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)

**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)

#### Organization Study ID Info
**ID:** MexidolPOAG2024
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharmasoft
### Status Module
#### Completion Date
**Date:** 2024-02-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-29

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pharmasoft

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Primary Open-Angle Glaucoma (POAG)

**Keywords:**

- Glaucoma

- Primary Open-Angle Glaucoma (POAG)

- Glaucomatous Optic Neuropathy (GON)

- Mitochondrial Dysfunction

- Neuroprotection

- Mexidol

- Ethylmethylhydroxypyridine Succinate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Mexidol

**Label:** Main (Mexidol and standard therapy)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** IOP normalizing therapy

**Label:** Control (standard therapy)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Main (Mexidol and standard therapy)

**Description:** Neurocytoprotector

**Name:** Mexidol

**Other Names:**

- Ethylmethylhydroxypyridine Succinate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)

**Measure:** Degree of expression of mitochondrial dysfunction

**Time Frame:** 90 days

**Description:** Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)

**Measure:** Dynamics of the structural and functional characteristics of mitochondria

**Time Frame:** 90 days

#### Secondary Outcomes

**Description:** Dynamics of index of mean deviation (MD) of retinal photosensitivity \[Static Automated Perimetry (SAP)\]

**Measure:** Аssessment of differential light sensitivity of the retina

**Time Frame:** 90 days

**Description:** 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)

**Measure:** Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters]

**Time Frame:** 90 days

**Description:** Adverse events related to Mexidol

**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tyumen

**Country:** Russian Federation

**Facility:** Tyumen Scientific Center of the Russian Academy of Sciences

**Zip:** 625026

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009798

- Term: Ocular Hypertension

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M9014

- Name: Glaucoma, Open-Angle

- Relevance: HIGH

- As Found: Primary Open Angle Glaucoma

- ID: M12832

- Name: Optic Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M12731

- Name: Ocular Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

- ID: D000005902

- Term: Glaucoma, Open-Angle

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M249938

- Name: Emoxypine succinate

- Relevance: HIGH

- As Found: Gene analysis

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000070020

- Term: Emoxypine succinate

### Misc Info Module

- Version Holder: 2024-05-31
