Retinalamin

UNLABELLED: Purpose - to investigate functional and morphological effects of peptide bioregulator (Retinalamin) in modeling of photochemical damage to rabbit retina. MATERIAL AND METHODS: The study was conducted on 36 rabbits (72 eyes) randomized into 4 equal groups: two experimental groups received parabulbar injections of Retinalamin («Geropharm», Russia) in each eye in dosages of 0.25 mg/kg in a course of 10 days starting from day 1 and day 10 of the experiment, respectively, and two control groups that received injections of normal solution with the same regimen. To simulate photochemical damage to the retina, exposure to light with a wavelength of 405 nm, a power density of 5 mW/cm2 and daily exposure time of 4 h was performed for 20 days. Multifocal and flicker 30 Hz electroretinogram (mfERG and fERG) were recorded, and histological studies of retina samples with quantitative assessment of retinal cells apoptosis by the TUNEL method were conducted before, as well as 10, 20 and 30 days after the start of light exposure. RESULTS: Ophthalmoscopic signs of light-induced retinal degeneration were revealed 6-10 days after start of exposure in all groups. When registering mfERG and fERG in all groups, there was a significant decrease in the amplitude of N1 and P1 peaks, retinal density of the bioelectric response of the P1 component, as well as the amplitude of fERG on days 10 and 20 after the beginning of light exposure (p<0.001 in comparison with the background values), and a slight increase in the indicators on day 30. Histological examination revealed a significant decrease in the number of cells in the outer nuclear layer and an increase in the proportion of apoptotic cells in the outer and inner nuclear layers on days 10 and 20 of the experiment, with a decrease on day 30 (after cessation of light exposure). Comparison of the groups receiving Retinalamin injections from days 1 or 10 of light exposure between themselves and the control groups revealed no significant differences in any of the studied parameters (p>0.05). CONCLUSION: No significant functional and morphological evidence of neuroprotective effects of Retinalamin were found in the model of photochemical damage to rabbit retinas.

The efficiency of the peptide bioregulator retinalamine in the complex treatment of patients with tuberculous chorioretinitis was studied. Ninety-seven patients (69 females and 28 males) with inactive tuberculous chorioretinitis (132 eyes) were followed up. According to the treatment option, the patients were divided into 2 groups: a study group and a control one. Parabulbar injections of retinalamine were used in the study group. The conventional treatment using parabulbar injections of emoxipine (an agent from the group of synthetic antioxidants) was performed in the control group. The results of treatment were assessed by visual acuity, the number of pathological scotomas in the field of vision and the findings of electrophysiological investigations (EPI). Analysis of the results of conventional versus peptide bioregulator therapy used in patients with inactive tuberculous chorioretinitis showed the advantages of retinalamine. This manifested itself as increased visual acuity in 66.3% of the patients receiving retinalamine while in the emoxipine-treated patients, visual acuity increased only in 20% of cases. In the patients taking retinalamine, the positive changes in the field of vision were statistically significant in the number of normal test objects, relative and absolute scotomas while in the emoxipine group, only the reduction in the number of absolute scotomas was significant. The values of EPI suggest that the peptide bioregulator is more effective in enhancing the functional activity of retinal neurons than the synthetic antioxidant.

The efficacy of the bioregulator retinalamine in the complex pathogenetic treatment was studied in patients with ocular tuberculosis. Ninety-seven patients (132 eyes) with tuberculous chorioretinitis in the inactive phase were examined. According to the treatment option, the patients were divided into 2 groups: 1) a study group and 2) a control one. Parabulbar injections of retinalamine were made in the study group. In the control one, conventional treatment was used as parabulbar injections of emoxypine (a synthetic antioxidant). As compared with the traditional treatment, retinalamine used in the treatment of patients with tuberculous choriorenitis without clinical signs was ascertained to substantially to improve retinal functional activity, as manifested as a 66.3% increase in visual acuity, a reduction in abnormal scotomas in the field of vision in 72.7% of cases, and electrophysiological parameters as the enhanced activity of the first retinal neuron in 88.3% of case, as shown by the ganz-feld electroretinogram and in 14.3% of cases, as indicated by macular electroretinogram. The higher activity of the second retinal neuron was recorded in 89.6 and 58.4% of cases, as seen in the ganz-feld and macular electroretinograms, respectively. Moreover, inclusion of retinalamine into the complex treatment in patients with tuberculous chorioretinitis slowed down the maturation rate of concomitant age-related cataract and prevented diminished vision in 97.8, 95.6, 66.7, and 53.3% of cases within the first, second, third, and fourth years after treatment, respectively.

PURPOSE: To evaluate the efficacy and safety of intramuscular Retinalamin for retinoprotection in patients with open-angle glaucoma and normalized intraocular pressure (IOP). MATERIAL AND METHODS: The study included 180 patients (355 eyes) randomized into the main (n=90) and control groups (n=90). The patients of the main group received intramuscular Retinalamin injections; the course was repeated 6 months later. Patient examination was performed at 1, 3, 6, 7, 9 and 12 months. RESULTS: Vision acuity did not change in the main group after the treatment courses (p=0.3732, p=0.6862), nor in the control group (p=0.7751). IOP didn't have significant changes during the whole course of the study neither in the main group (p=0.7632), nor in the control group (p=0.3921). MD index in the main group has increased from -5.52±2.76 to -4.82±2.73 dB (measurements from 6 visits: p=0.0391, p=0.0201, p=0.0302, p=0.3708, p=0.0151, p=0.0353). Control group showed negative MD trend (from -3.51±1.84 to -4.60±2.61 dB; p=0.0012). PSD index has changed from 4.63±1.60 to 4.05±1.43 dB (p=0.0081) in the main group, and from 3.73±1.19 to 4.29±1.53 dB (p=0.0027) in the control group. Average thickness of retinal nerve fiber layer (RNFL) and the volume of neuroretinal rim were stable in both the main (p=0.8039, p=0.9005) and the control groups (p=0.7448, p=0.9620). Ganglion cell complex (GCC) thickness remained stable in the main group (p=0.0377), but has decreased in the control group (p=0.0250). P50 amplitude and latency were stable in the main group (6.54±2.61-6.53±2.64 µV, p=0.0479; 48.39±3.69-50.86±4.09 ms, p=0.0271), while in the control group P50 amplitude has decreased (p=0,0031) and the latency has increased (p=0,0194). In the main group, N95 amplitude has stabilized (p=0.0141) with worsened latency (p=0.0492). N95 amplitude in the control group has worsened (p=0.0195), while latency has stabilized (p=0.3401). CONCLUSION: Systemic use of Retinalamin has significant retinoprotective effect confirmed by the dynamics of morphological and functional parameters in patients with POAG and IOP compensation.

PURPOSE: This study aimed to assess the changes in structural and functional characteristics of the visual analyzer in patients with advanced primary open-angle glaucoma (POAG) in the course of long-term regular use of Retinalamin (Geropharm, Russia). MATERIAL AND METHODS: The study was conducted from 2022 to 2024 at two clinical centers: the M.M. Krasnov Research Institute of Eye Diseases and the Chelyabinsk Glaucoma Center. This multicenter cohort prospective study examined the structural and functional parameters of the visual analyzer in patients with advanced POAG during long-term regular use of Retinalamin. UNLABELLED: The study included a total of 56 patients (98 eyes) divided into two groups. The observation group comprised patients with advanced glaucoma who regularly received 10 intramuscular injections of Retinalamin 5 mg (Geropharm, Russia) diluted in 1.0 mL of 0.9% sodium chloride solution in outpatient setting once every three months over a two-year period. The control group consisted of patients with advanced glaucoma who did not receive neuroprotective therapy. RESULTS: At baseline, all patients in both groups had achieved target intraocular pressure (IOP) through surgical and/or medical treatment, which remained stable throughout the follow-up period. UNLABELLED: The mean deviation (MD) decreased by 0.98 (0.78; 1.76) dB/year in the observation group and by 1.65 (0.59; 1.79) dB/year in the control group. The pattern standard deviation (PSD) increased by 0.02 (-0.3; 1.2) dB/year in the observation group and by 0.3 (0.7; 1.3) dB/year in the control group. Mean retinal nerve fiber layer (RNFL) thickness showed a similar trend. Following repeated courses of Retinalamin therapy, the observation group demonstrated stable, minimal decrease in RNFL thickness amounting to 1.5 (-0.25; 5.0) μm/year. The control group exhibited more pronounced decrease in RNFL thickness averaging 3.0 (0.75; 10.2) μm/year. CONCLUSION: Long-term neuroretinoprotective therapy with Retinalamin (Geropharm, Russia) in patients with advanced POAG is justified when administered regularly and the intraocular pressure is stable and well controlled.

PURPOSE: To evaluate the effectiveness of neuroprotective therapy in patients with primary open-angle glaucoma based on specific biochemical markers of neurotrophy and neurodegeneration. MATERIAL AND METHODS: In the course of the study, lacrimal fluid (LF) of 23 patients (46 eyes) with stage I-II primary open angle glaucoma (POAG) aged 66.3±10.8 was examined. The control group consisted of healthy individuals (12 control LF samples). Local antihypertensive therapy was complimented with 10 intramuscular injections of retinalamin (GEROPHARM LLC, St. Petersburg) - a complex of peptides isolated from cattle retinas, administered 5 mg once a day. Enzyme immunoassay (ELISA) method was used to test LF for concentrations of brain-derived neurotrophic factor (BDNF) and neuron specific enolase (NSE) before and after the treatment. RESULTS: In healthy subjects, the content of BDNF was 0.83±0.06 ng/mL, NSE - 0.51±0.06 ng/mL. In patients with POAG, the indices were higher: BDNF was 1.39±0.85 ng/mL (p>0.05), NSE - 4.31±2.02 ng/mL (p<0.05). The patients with stage II-III POAG had a significant increase of BDNF concentration (1.37±0.41 ng/mL and 1.52±0.40 ng/mL respectively in stages II and III) indicating compensatory capabilities at these stages of the disease. The NSE marker was also high in these stages (4.16±2.44 ng/mL and 5.78±2.80 ng/mL, p<0.05), which indicates the degeneration of retinal ganglion cells. After Retinalamin® therapy, patients with stage II POAG had control group levels of marker proteins, while in stage III patients NSE content remained high. CONCLUSION: There is a compensatory increase of BDNF level and a pathological increase of NSE content in LF of POAG patients. The change in the content of neurotrophins in the LF was determined to depend on the stage of POAG. Thus, in stages II and III POAG there is a marked increase of NSE and a compensatory increase of BDNF. After the complex therapy including retinalamin in patients with stage II POAG, a decrease in initially high concentrations of BDNF and NSE in LF down to the control group values was noted. In stage III patients, signs of neurodegeneration persist in the form of high NSE values. Taking into account the positive dynamics of the neuronal marker content in LF in the complex therapy of POAG with Retinalamin®, timely neuroretinoprotection is recommended.