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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Kirov Regional State Budgetary Healthcare Institution "Kirov Clinical Ophthalmological Hospital"
Kirov, Russia
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, Russia
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
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
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
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Moscow, Russia
Budgetary healthcare institution of the Omsk region "V.P. Vyhodtsev Clinical Ophthalmological Hospital"
Omsk, Russia
Saint Petersburg State Budgetary Healthcare Institution "State Hospital No. 40 of the Kurortny District"
Saint Petersburg, Russia
Private healthcare institution "Clinical hospital "RZhD-Medicine" of the city of Saratov"
Saratov, Russia
State Budgetary Institution of Healthcare of the Yaroslavl Region "Clinical Hospital No. 2"
Yaroslavl, Russia
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