A report of the results of clinical study of the biologically active Peptide Bioregulator of Retina Origin

Biologically active food supplement the Retina Bioregulator contains a complex of low molecular weight peptides with a molecular weight of up to 5000 Da, isolated from the tissues of the eyes of young animals – calves up to 12 months of age or pigs.

The Nature’s Marvels Retina Bioregulator is available in capsules with an active substance content of 10 mg.

The Retina Bioregulator peptides regulate metabolic processes in the cells of the eye tissues, increase the reserve capabilities of the organ of vision, have a beneficial effect on the adaptation processes of the body in extreme conditions, have antioxidant properties, and regulate the processes of peroxidation in the tissues of the eye. Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tissues from which they are isolated. This allows us to assume the effectiveness of the use of the Retina Bioregulator for the restoration of visual functions in case of disorders of various origins.

According to experimental data, the Retina Bioregulator promotes the normalization of functional and morphological disorders of the organ of vision. The development of treatment tools that allow for the complete rehabilitation of patients with eye injuries and their consequences, dystrophic diseases of various eyeball structures is an urgent and complex problem in ophthalmology. Hereditary or post-traumatic insufficient vitality of eye tissues often leads to their progressive destruction (1, 2).

Drug treatment of these diseases includes the use of the following drugs (1, 3):
– Vitayodurol, vitafacol;
– Vitamins B1, B6;
– Biostimulants (aloe, FiBS);
– etc.

The clinical study of the Retina Bioregulator was carried out at the Medical Center of the St. Petersburg Institute of Bioregulation and Gerontology from January to August 2011.

A clinical trial of the Retina Bioregulator was carried out in patients with dystrophic diseases of the retina of the eye of various etiologies and post-traumatic endothelial-epithelial corneal dystrophies. The study involved 49 patients randomly divided into 2 groups – the control group (20 people) and the primary group (29 patients). The distribution of patients by groups is shown in Table 1.

Patients in the control group received conventional therapy. In addition to conventional treatment, patients of the primary group were prescribed the Retina Bioregulator orally 10-15 minutes before meals, 1-3 capsules 2-3 times a day for 30 days, depending on the severity of the pathological process. For post traumatic visual impairments, the Retina Bioregulator was prescribed in the rehabilitation period after surgery.

A progressive narrowing of the visual fields decreased visual acuity, degenerative changes in the retina and narrowing of the retinal vessels were registered when examining patients.

Table 1

Distribution of patients by diagnosis, sex and age.

Research Methods

All patients before and after the course of treatment were examined according to a comprehensive clinical program, including, along with the obligatory – traditional methods, methods for diagnosing and clarifying visual impairment, blood flow velocity, the state of the outer and inner layers of the retina, the state of the retinal pigment epithelium.

Traditional examination methods included: a study of visual acuity and visual field, a study of dark adaptation, a study of intracranial pressure, biomicroscopy of the anterior segment of the eyes, deep optical media, biomicro-ophthalmoscopy, stereophthalmoscopy, direct ophthalmoscopy.

Diagnostic and clarifying examination methods included: visocontrastometry, static and multiple central perimetry, color perception study, fundus fluorescence angiography, Doppler sonography, electrophysiological studies.

Research Results

Evaluation of clinical and laboratory functional parameters revealed changes in all parts of the eyeball (iris, lens, vitreous body, optic nerve) in patients with degenerative diseases of the retina, which means generalization of the pathological process with a tendency to progress as the disease progresses.

As a result of the studies, it was found that in the case of application of the Retina Bioregulator in addition to the conventional treatment, the maximum therapeutic effect was observed in patients with the initial stages of degenerative changes in the retina. This was manifested in an increase in visual acuity and an improvement in the electrophysiological parameters of the retina, the results of fluorescent angiography, and changes in visual fields (expansion of the peripheral boundaries, reduction or disappearance of paracentral scotomas). The research results are presented in tables 2 and 3.

Influence of the Retina Bioregulator on the dynamics of visual acuity in patients with degenerative diseases of the retina:

So, from the data in Table 2, it can be seen that when additional the Retina Bioregulator was included in the treatment regimen for patients of the primary group, visual acuity significantly increased in most patients: the number of patients with visual acuity from 0.9 to 1.0 increased from 8.1% to 15, 7%, and patients with visual acuity from 0.2 to 0.8 – from 56.2 to 67.8%, while the number of patients with visual acuity below 0.1 – from 35.7% to 16.5 %. The pain indicators in the control group indicate the insufficient effectiveness of the conventional treatment: the number of patients with visual acuity from 0.9 to 1.0 after the course of treatment remained practically unchanged, and the number of patients with low visual acuity (from 0.0 to 0.1 ) decreased slightly – from 35.7% to 28.3%.

These data are consistent with the results of the electrophysiological study shown in Table 3. From the data in Table 3, it can be seen that the electroretinography indices of both the «A» and «B» waves, with the additional inclusion of the Retina Bioregulator in the treatment regimen, significantly increase in comparison with the indicators before treatment and with indicators in the control group and approaching the physiological norm. The indicators in the control group, whose patients received conventional treatment, significantly differ from the before treatment but do not reach the boundaries of the physiological norm.

The use of the Retina Bioregulator in post-traumatic keratoconjunctivitis had a stimulating effect on the cornea’s reparative regeneration, promoting the formation of more delicate corneal scars, increasing the effectiveness of the treatment by 1.4 times and providing a more stable therapeutic effect in comparison with the results in the control group. The phenomena of blepharospasm, photophobia, and lacrimation in patients receiving the Retina Bioregulator disappeared 2.4 times faster than in the control group.

The effect of the Retina Bioregulator on electroretinography indicators in patients with degenerative diseases of the retina

* p <0.05 – statistically significant in comparison with the indicator before treatment;
# p <0.05 – statistically significant in comparison with the indicator in the control group,

The appointment of Nature’s Marvels Retina Bioregulator in the postoperative period after keratoplasty and vitreoretinal operations made it possible in 86.7% of cases to prevent postoperative complications and shorten the rehabilitation period. Nature’s Marvels Retina Bioregulator does not cause side effects, complications, or drug dependence.

The obtained results from the clinical study of the drug indicate the therapeutic efficacy of the Retina Bioregulator and the practicality of its use in the complex treatment of patients with dystrophic diseases of the retina and post-traumatic epithelial-endothelial corneal dystrophies, keratoconjunctivitis, as well as in the postoperative period in combination with symptomatic and pathogenetic drugs as an additional agent

Conclusion

The biologically active food supplement Retina Bioregulator has a normalizing effect on the metabolism of the eyeball tissues and helps restore the optical structures of the eye. Nature’s Marvels Retina Bioregulator is well tolerated when taken orally, has no side effects, and can be widely used as a therapeutic and prophylactic biologically active food supplement.

Nature’s Marvels Retina Bioregulator is recommended for use:

– To patients with degenerative diseases of the retina – orally 10-15 minutes before meals, 1-3 capsules 2-3 times a day for 15-30 days, depending on the severity of the pathological process;

– To patients with post-traumatic corneal dystrophies – orally 10-15 minutes before meals, 2-3 capsules -3 times a day for 15-30 days, depending on the severity of the pathological process;

– For prophylactic purposes in people whose professional activity is associated with eye strain, work in dusty and smoky rooms – orally 10-15 minutes before meals, 1 capsule 2 times a day for 15-30 days.

According to indications, a second course of treatment is recommended after 3-6 months.

It is advisable to recommend Nature’s Marvels Retina Bioregulator for therapeutic and prophylactic use and industrial production.

References

1. Danilichev V.F., Khavinson V.Kh., Vasilieva L.A. Treatment of peripheral pigmentary tapetoretinal
abiotrophy // Ophthalmological journal. – 1992. – No. 3. – S. 174 – 178.
2. Maksimov I.B. Complex peptide correction in microsurgical treatment of eye injuries and their
consequences (experimental clinical study): Abstract of the thesis. diss. …. Dr. med. sciences. – M.,
1996 .– 36 p.
3. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.

Recommendations For Use

Nature’s Marvels Retina Bioregulator is a complex of peptides obtained from the tissues of the eyes of young animals. The isolated peptides have a selective effect on various cells of the eye’s tissues (retina, lens, cornea), normalize metabolism in cells, and regulate their functions.

In the clinical study, the effectiveness of Nature’s Marvels Retina Bioregulator was established for the complex restoration of the functions of the organ of vision after diseases of various origins, including monetary-dystrophic, in pathological conditions leading to impaired visual function, exposure to extreme environmental factors, including occupational, malnutrition, as well as aging.

Instructions: 1-2 capsules or tablets of Nature’s Marvels Retina Bioregulator 1-3 times a day with meals. The duration of admission is 30 days. It is advisable to repeat the course in 4-6 months.

Do not use in case of: individual intolerance to the components, pregnancy, breastfeeding.
No side effects have been identified while using the Nature’s Marvels Retina Bioregulator.

Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of Nature’s Marvels Retina Bioregulator.
Expiration date: 5 years from the date of manufacture.