"Retinalamin": Instructions for use, analogues and reviews

Directions for use and dosage

Adult patients

To prepare the Retinalamin solution, the powder is dissolved in water for injection, 0.9% saline solution of sodium chloride or 0.5% solution of procaine (novocaine).

For the treatment of taperetinal abiotrophy, diabetic retinopathy, central retinal dystrophies, compensated open-angle glaucoma, Retinalamin solution is prescribed intramuscularly or parabulbarly in an amount of 5–10 mg once daily. The course of treatment can last 5 - 10 days, it can be repeated after 3 months or six months.

For myopic disease, Retinalamin solution is administered parabulbarly once daily at 5 mg for up to 10 days.

Children 1–5 years old

In the treatment of central retinal dystrophies and taperetinal abiotrophy, injections of the drug are prescribed parabulbarly or intramuscularly once, 2.5 mg daily.

Children 6–18 years old

In the treatment of central retinal dystrophies and taperetinal abiotrophy, parabulbar or intramuscular injections of the drug are prescribed daily, in a single dose of 2.5 or 5 mg. The course of treatment is up to 10 days, it can be repeated after 3 months or six months.

Side effects, complications and contraindications

Parabulbar injections of Retinalamin are considered one of the most effective ways to deliver medication to the affected area, but they are very painful and can be accompanied by bruising and itchy swelling under the eyes, as well as allergic reactions.

Among the possible negative effects of the procedure, experts also mention:

• The appearance of a veil before the eyes, which reduces visual acuity.
• Hemorrhages under the conjunctiva.
• Severance of the ligaments of zinn (rare).
• Iris prolapse (very rare).

Retinalamin injections are not prescribed if you are hypersensitive to the components of the product. Limitations also include age under 18 years (children with central retinal dystrophy are excluded) and pregnancy. Women who are breastfeeding are advised to temporarily stop breastfeeding when prescribed Retinalamin injections.

Experience in using Retinalamin for various ophthalmological diseases

Dystrophic eye diseases such as glaucoma, AMD, diabetic retinopathy, myopia and its complications are common causes of low vision and blindness throughout the world. In addition, there is a tendency towards an increase in the frequency of these diseases, including at a young age [1–4]. The last decade has been marked by the accumulation of new data on the role and place of neuroprotective therapy in the treatment of dystrophic eye diseases. Neuroprotection can be defined as a set of therapeutic measures aimed at preventing, reducing, and in some cases reversing the processes of death of neuronal cells. One of the significant groups of neuroprotectors are biogenic peptides. The first studies on the use of this group of drugs in ophthalmology were conducted in the early 1980s. at the Department of Ophthalmology of the Military Medical Academy, i.e., the experience of their use is more than 30 years. Retinalamin, which is a representative of this group of drugs, is a complex of water-soluble polypeptide fractions. The mechanism of action of the drug is determined by its metabolic activity. Retinalamine improves metabolism in eye tissues and normalizes the functions of cell membranes, intracellular protein synthesis, regulates lipid peroxidation processes, and helps optimize energy processes. In vitro studies of the effect of Retinalamin on the survival of nerve cells and the state of cultured retinal cells under conditions of oxidative stress were carried out in 2006–2007. on the basis of the Institute of Molecular Genetics of the Russian Academy of Sciences. The effect of Retinalamin was expressed in high cytoprotective activity, increased proliferation and stimulation of the transformation of stem cells into neurons, which ensured their connections with the nervous structures of the brain and restoration of visual function. Moreover, the protective effect on cells was observed both before and after the creation of conditions of oxidative stress. Thus, the drug has indications for use for both preventive and therapeutic purposes. Thus, Retinalamin has a stimulating effect on photoreceptors and cellular elements of the retina, helps improve the functional interaction of the pigment epithelium and outer segments of photoreceptors during dystrophic changes, and accelerates the restoration of light sensitivity of the retina. Against this background, vascular permeability is normalized, reparative processes are activated in diseases and dystrophic lesions of retinal and optic nerve cells [5–10]. In 2021, an observational clinical study of Retinalamin was conducted in daily clinical practice in patients with various ophthalmological pathologies within the framework of registered indications for use. This study was approved by an independent multidisciplinary clinical research ethics review committee. Purpose of the study:

assessment of the effectiveness and tolerability of Retinalamin in patients with various ophthalmological diseases during 1 or 2 consecutive courses of treatment with an interval of 3 months.

Material and methods

The study included patients over the age of 18 years with “dry” or “wet” AMD, POAG with compensated IOP, diabetic retinopathy and myopic disease. Each patient signed an informed consent to participate in the study. Exclusion criteria included age <18 years, the presence of contraindications to the use of Retinalamin, a single eye, VA in the worse eye <0.1 with correction, any other serious diseases or conditions that, in the opinion of the study physician, could distort the results of the observational program and limit patient participation in the study, as well as pregnancy and breastfeeding. The total number of patients was 4172 people (64% women and 36% men). The average age of the patients was 59±17 years. The distribution by nosology in the study groups was as follows: “dry” or “wet” form of AMD – 894 people, average age – 51.3±9.2 years; POAG with compensated IOP – 1269 people, average age – 62.1±10.7 years; diabetic retinopathy – 943 people, average age – 42.8±7.9 years; myopic disease – 1066 people, average age – 34.5±13.6 years. Follow-up visits were scheduled at 1, 3, 4, and 6 months to assess the effectiveness and tolerability of retinoprotective therapy. from the start of therapy if 2 courses of Retinalamin are prescribed. During the 1st course of treatment with Retinalamin, patients were examined after 1, 3 and 6 months. from the start of therapy. Efficiency assessment was carried out based on changes in health and health status (expansion of health zone boundaries in total, reduction in the number of scotomas and changes in MD1, PSD2 indicators). To assess the quality of life of the study participants, a “Patient Questionnaire” was used, in which there were 7 situations for assessment, each of which contained 5 categories (1 – I have no difficulties; 2 – I have minimal difficulties; 3 – I have moderate difficulties; 4 – I have enough severe difficulties; 5 – experiencing extreme difficulty). Tolerability of Retinalamin was assessed by the frequency of adverse events (AEs).

results

The dynamics of VA during therapy are shown in Fig. 1. There was a trend towards an increase in VA, most pronounced in most cases after 3 months. therapy. The results of the PZ study were divided into 2 groups depending on the perimetry method used. Kinetic perimetry was used in 37% of observations; its use was associated both with the equipment of diagnostic centers and with limitations for standard automatic perimetry (low VA, complexity of the technique). The dynamics of the peripheral boundaries of the PZ were assessed by the sum of 8 meridians (Σ, in degrees) and the number of scotomas (Fig. 2, 3). Changes in static perimetry results were assessed by changes in the main photosensitivity indices: MD - average decrease and PSD - pattern deviation (Fig. 4, 5).

All changes in perimetry results were statistically insignificant (p>0.05). There was a trend towards improvement in visual function during observation. Pronounced positive dynamics of VA with correction, perimetric indices, an increase in the peripheral boundaries of the VA, and a decrease in the number of scotomas were observed at 1 and 3 months. from the start of therapy. Subsequently, stabilization was observed in most of the assessed indicators. The difference in responses to the “Patient Questionnaire” at different follow-up periods was not significant, however, there was a slight decrease in the total score during Retinalamine therapy, which indicates a tendency to improve the quality of life of patients. The difference in responses between nosological groups is most likely due to the characteristics of the clinical picture of the diseases. Tolerability of Retinalamin in patients with various ophthalmological diseases during 2 consecutive courses with an interval of 3 months. was good, no adverse events were identified during the study.

Discussion

In recent years, a number of large domestic studies have been conducted on the effectiveness of Retinalamin in patients with POAG of various stages, AMD, diabetic retinopathy, and myopic disease. The use of Retinalamin in a pathology such as diabetic retinopathy contributed to the improvement of basic visual functions, electrophysiological and hemodynamic parameters (decrease in linear blood flow velocity parameters and decrease in the resistance index) [11]. With progressive myopia in children, Retinalamin had a positive effect on VA and contributed to the expansion of peripheral VA [12]. The clinical effectiveness of treatment with Retinalamin in the “dry” form of AMD has been confirmed both with subconjunctival and parabulbar administration of the drug. The effectiveness of treatment was assessed after 3 and 6 months. [13]. At the Department of Ophthalmology, Faculty of Medicine, Russian National Research Medical University, the effect of prescribing 2 courses of Retinalamin with a break of 3 months was studied. Positive dynamics of the studied indicators were revealed, and the effect increased gradually, and after 1 month. after completion of therapy, the main indicators exceeded the indicators identified immediately after the end of the course of treatment. After the 2nd course of therapy, an increase in the effect of the drug was noted [14]. In 2007, a study was conducted involving 120 patients with POAG. Starting from 3 months after treatment with Retinalamin, positive dynamics of the studied parameters were observed, including contrast sensitivity [15]. In a 2013 study, clinically significant results after using Retinalamin were noted after 3, 6, 12 months. There was an expansion of the boundaries of the PV, an increase in VA, the average thickness of retinal nerve fibers, and stabilization of the glaucomatous process according to ophthalmoscopy. In the control group, by the end of the observation period, most patients showed progression of POAG [16]. In the period from November 2013 to May 2014, a nationwide screening study was conducted on the effectiveness of Retinalamin in patients with compensated POAG stages I–III. The study included 453 patients (453 eyes) aged from 28 to 89 years. Retinalamine was administered to all patients at a dose of 5 mg IM for 10 days. The total observation period was 3 months. During this time, the protocol provided for 4 control examinations of patients: before treatment, after 10 days, 1 and 3 months. after it started. Standard ophthalmological examination, ophthalmoscopy and perimetry were performed. It was found that improvement in indicators (VA, PV, IOP) after a course of Retinalamin occurs within 3 months. [17]. Thus, the results of the clinical use of Retinalamine in various diseases do not contradict the data of previously conducted studies and confirm its effectiveness for the prevention and relief of changes in retinal tissue and improvement of its functions.

Conclusion

When prescribing Retinalamin in patients with AMD, glaucoma, diabetic retinopathy, myopic disease in the form of 2 consecutive courses with an interval of 3 months.
Positive dynamics of the average VA and a tendency to increase the photosensitivity of the retina were observed (expansion of the borders of the retina, a decrease in the number of scotomas and changes in MD and PSD indicators). Retinalamin can be recommended as a universal neuroprotector for various ophthalmological diseases associated with degenerative lesions of retinal tissue. 1 MD (mean deviation), the average deviation from the age norm, shows general depression or the presence of areas in the visual field with normal light sensitivity and defects. 2 PSD (pattern standard deviation), partial standard deviation, represents the degree of deviation of the shape of the patient’s hill of vision from the age norm.