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

Primary Open-Angle Glaucoma (POAG) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437639
• Other study ID #: MexidolPOAG2024
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: May 2024
• Source: Pharmasoft
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2, 2024
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-Angle Glaucoma (POAG)

Intervention

Drug:
• Mexidol
Neurocytoprotector

Locations

Country	Name	City	State
Russian Federation	Tyumen Scientific Center of the Russian Academy of Sciences	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Pharmasoft

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of expression of mitochondrial dysfunction	Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)	90 days
Primary	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)	90 days
Secondary	?ssessment of differential light sensitivity of the retina	Dynamics of index of mean deviation (MD) of retinal photosensitivity [Static Automated Perimetry (SAP)]	90 days
Secondary	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)	90 days
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse events related to Mexidol	90 days