OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multicenter, double-masked, randomized, controlled phase III trial. PARTICIPANTS: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

• Klíčová slova
• Biosimilar, Lucentis, Neovascular age-related macular degeneration, QL1205, Ranibizumab,
• MeSH
• biosimilární léčivé přípravky * aplikace a dávkování   MeSH
• dvojitá slepá metoda MeSH
• inhibitory angiogeneze aplikace a dávkování   škodlivé účinky   MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• optická koherentní tomografie MeSH
• ranibizumab * aplikace a dávkování   škodlivé účinky   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• vaskulární endoteliální růstový faktor A antagonisté a inhibitory   MeSH
• vlhká makulární degenerace * farmakoterapie   diagnóza   MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• zraková ostrost * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• biosimilární léčivé přípravky * MeSH
• inhibitory angiogeneze MeSH
• ranibizumab * MeSH
• vaskulární endoteliální růstový faktor A MeSH

OBJECTIVES: To describe the pattern and mutual relationships between basic biometric characteristics of the eye in a Central European Caucasian population. METHODS: A single-centre retrospective study of 2340 patients (965 males, 1375 females) scheduled for cataract surgery between 2014 and 2016. Measurements using laser interferometry included AL (axial length), K (average corneal curvature), ACD (anterior chamber depth), LT (lens thickness), CCT (central corneal thickness), AST (astigmatism) and WTW (white to white). Subjects were stratified by gender and controlled for age. Descriptive, correlation and regression analyses were performed on the data. RESULTS: The mean AL was 23.33 ± 1.01 mm - higher in males (23.59 ± 0.99 mm), in comparison to females (23.15 ± 0.99 mm). The elderly had lower ACD and higher LT, while males had higher AL independent of age. Furthermore, LT and K decreased with AL, while ACD decreased with LT and increased with AL independent of age and gender. CONCLUSIONS: The estimates of the biometrics are obtained on a large sample of subjects and can serve as normative values for Lenstar LS900 in the Central European Caucasian population.

• Klíčová slova
• Caucasian, Lenstar LS900, Optical biometry, axial length, cataract, lens thickness,
• MeSH
• axiální délka oka MeSH
• biometrie MeSH
• katarakta * diagnóza   MeSH
• lidé MeSH
• oční čočka * MeSH
• optická koherentní tomografie MeSH
• přední komora oční MeSH
• retrospektivní studie MeSH
• rohovka MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

PURPOSE: To study the association of serum ionic calcium and glycated hemoglobin (HbA1c) with retinal photoreceptor ellipsoid zone (EZ) disruption in diabetic retinopathy (DR). METHODS: This is a tertiary care center-based observational cross-sectional study. Sixty-three consecutive cases, divided into 21 cases each with no diabetic retinopathy, non-proliferative diabetic retinopathy and proliferative diabetic retinopathy were included. Twenty-one healthy controls were also included. Ellipsoid zone disruption was assessed using spectral-domain optical coherence tomography. Serum ionic calcium and HbA1c were measured using standard protocol. Patient data from cases were divided into two groups according to their HbA1c levels: group 1 (HbA1c < 7, n = 26) and group 2 (HbA1c > 7, n = 37). Data were analyzed statistically. RESULTS: Mean ionic calcium levels in group 1 and group 2 were 1.131 ± 0.073 mmol/dL and 1.170 ± 0.070 mmol/dL, respectively. In group 1, 11 out of 26 had EZ disruption (42.3%). Similarly, in group 2, 29 out of 37 had EZ disruption (78.4%). On logistic regression analysis, as compared to group 1, ellipsoid zone disruption was found to be positively associated with serum ionic calcium (p = 0.01) in group 2 cases. CONCLUSION: Increased levels of serum ionic calcium are associated with increased EZ disruption in patients with HbA1c > 7 in DR.

• Klíčová slova
• Diabetic retinopathy, Ellipsoid zone, Glycated hemoglobin, Serum calcium, Spectral-domain optical coherence tomography,
• MeSH
• analýza rozptylu MeSH
• diabetická retinopatie patofyziologie   MeSH
• dospělí MeSH
• fotoreceptory obratlovců patologie   MeSH
• glykovaný hemoglobin analýza   MeSH
• hyperglykemie patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• průřezové studie MeSH
• senioři MeSH
• studie případů a kontrol MeSH
• vápník krev   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• Názvy látek
• glykovaný hemoglobin MeSH
• vápník MeSH

PURPOSE: To study the correlation between disorganization of inner retinal layer (DRIL) and macular thickness parameters, ellipsoid zone (EZ) disruption and retinal nerve fiber layer (RNFL) thickness on spectral domain optical coherence tomography (SD-OCT) in diabetic retinopathy (DR), for the first time. METHODS: A tertiary care center-based cross-sectional study was undertaken. One hundred and four consecutive study subjects of type 2 diabetes mellitus were included: diabetes mellitus with no retinopathy (No DR) (n = 26); non-proliferative DR (NPDR) (n = 26); proliferative DR (PDR) (n = 26) and healthy controls (n = 26). Best Corrected Visual Acuity (BCVA) was measured on the logarithm of the minimum angle of resolution (logMAR) scale. Clinician-friendly, SD-OCT based, grading systems were created for DRIL and EZ disruption, within the macular cube. DRIL was graded as: grade 0, DRIL absent; and grade 1, DRIL present. EZ disruption was graded as; Grade 0: Intact EZ; Grade 1: Focal disruption and Grade 2: Global disruption. Every study subject underwent RNFL thickness analysis. RESULTS: DRIL was significantly associated with increase in severity of DR.Pearson correlation analysis showed significant positive correlation between DRIL and CST CAT and grades of EZ disruption . However, a significant negative correlation was found between DRIL and RNFL thickness . CONCLUSION: Presence of DRIL correlates with severity of DR, EZ disruption and RNFL thinning.

• Klíčová slova
• Diabetic retinopathy, Disorganization of inner retinal layer (DRIL), Imaging biomarkers, Macular thickness parameters, Retinal nerve fiber layer (RNFL) thickness, Spectral domain optical coherence tomography (SD-OCT),
• MeSH
• diabetes mellitus 2. typu komplikace   MeSH
• diabetická retinopatie patologie   patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• macula lutea patologie   MeSH
• nervová vlákna fyziologie   MeSH
• optická koherentní tomografie MeSH
• průřezové studie MeSH
• retina patologie   patofyziologie   MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

PURPOSE: The aim of this work was to study the association of serum ionized calcium with retinal photoreceptor apoptosis on spectral domain optical coherence tomography (SD-OCT) in diabetic retinopathy (DR). METHODS: Sixty consecutive cases with Type 2 diabetes mellitus were categorized into three groups: no diabetic retinopathy; non-proliferative DR; proliferative DR. The eye with more severe form of the disease was considered. Twenty healthy controls were also included. Best corrected visual acuity (BCVA) was measured on logMAR scale. Retinal photoreceptor apoptosis was defined as disruption of retinal photoreceptor ellipsoid zone (EZ). Ellipsoid zone disruption was assessed using SD-OCT. Serum levels of total and ionized calcium were measured using standard protocol. RESULTS: EZ disruption was found to be positively associated with serum total calcium and ionized calcium. Also, EZ disruption was found to be positively associated with logMAR BCVA. CONCLUSION: Increased serum ionized calcium induces retinal photoreceptor apoptosis resulting in increased EZ disruption in DR.

• Klíčová slova
• Autophagy, Diabetic retinopathy, Ellipsoid zone, Ionized calcium, Retinal photoreceptor apoptosis, Spectral-domain optical coherence tomography,
• MeSH
• apoptóza * MeSH
• diabetická retinopatie krev   patologie   MeSH
• fotoreceptory obratlovců patologie   MeSH
• homeostáza MeSH
• lidé středního věku MeSH
• lidé MeSH
• optická koherentní tomografie MeSH
• vápník krev   MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• vápník MeSH

PURPOSE: Age-related macular degeneration (AMD) is one of the leading causes of blindness in the elderly population. Although there are prevalence studies for AMD in Europe, data are scarce for the Slovakian population. METHODS: This was a prospective, multicenter, non-interventional, mobile clinic-based cross-sectional study that assessed age-specific prevalence of AMD in the Slovakian population and risk factors associated with AMD. The type of AMD was graded based on the international age-related maculopathy grading system; optical coherence tomography (OCT) was used for the differential diagnosis. Overall, 3,278 patients were screened; the fundus photographs, OCT scans, and self-reports were collected at the mobile clinic in a single visit. RESULTS: The prevalence of AMD in the study population was 8.99% (wet AMD 1.01%; dry AMD 7.85%), whereas the extrapolated estimate in the entire Slovakian population was 3.3% (wet AMD 0.3%; dry AMD 3.0%). Age, smoking, and hypertension were risk factors associated with AMD; however, contrary to reports in the literature, no gender-specific association was observed. CONCLUSION: Based on the results of this study, mobile clinics may be an effective way to extend health care access to a larger population. Early diagnosis of AMD will assist in early treatment and effective disease management of the population at risk.

• Klíčová slova
• Age-related macular degeneration, epidemiology, mobile clinic, prevalence, risk factors,
• MeSH
• hodnocení rizik metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace diagnóza   epidemiologie   MeSH
• mobilní zdravotnické jednotky statistika a číselné údaje   MeSH
• optická koherentní tomografie MeSH
• prevalence MeSH
• prospektivní studie MeSH
• průřezové studie MeSH
• průzkumy a dotazníky MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• surveillance populace metody   MeSH
• věkové faktory MeSH
• věkové rozložení MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Geografické názvy
• Slovenská republika epidemiologie   MeSH

BACKGROUND: Diabetic retinopathy is a serious sight-threatening complication which is manifested by excessive angiogenesis in diabetic patients. AIM: We hypothesize that cultured Rhesus monkey retinal endothelial cells (RhRECs) respond to high glucose with a change in cell proliferation and vascular endothelial growth factor (VEGF) secretion. MATERIALS AND METHODS: In our study, 20 000 cells per well were treated without glucose or with 5.5 mM, 18.5 mM and 30 mM glucose for 24 hours. Viable cells were counted using trypan blue dye exclusion method. VEGF concentrations were measured in cell media by ELISA method. RESULTS: The number of viable cells incubated with 5.5 mM glucose increased significantly by 53.7% after 24 hours. In comparison, the number of viable cells decreased by 2.8% at 18.5 mM of glucose and by 20.4% at 30 mM of glucose after 24 hours of incubation. In contrast to this effect of glucose on the number of viable cells, a significant increase in VEGF levels (pg/mL) in the cell media with a glucose concentration of 0 mM compared to 5.5 mM of glucose was found. VEGF secretion in cell medium with 18.5 and 30 mM of glucose increased non-significantly in comparison with euglycemic levels. CONCLUSION: Our results show that viability of retinal endothelial cells and VEGF release are highly responsive to changes in glucose concentration. Such glucose-induced changes in retinal endothelial cells may negatively impact the integrity of the microvasculature in the diabetic retina leading to angiogenesis and microaneursym.

• Klíčová slova
• VEGF, diabetic retinopathy, glucose, retina, retinal endothelial cell,
• MeSH
• diabetická retinopatie patologie   patofyziologie   MeSH
• ELISA MeSH
• endoteliální buňky cytologie   MeSH
• glukosa metabolismus   farmakologie   MeSH
• Haplorrhini MeSH
• hyperglykemie komplikace   MeSH
• kultivované buňky MeSH
• lidé MeSH
• proliferace buněk účinky léků   fyziologie   MeSH
• referenční hodnoty MeSH
• retina cytologie   MeSH
• senzitivita a specificita MeSH
• vaskulární endoteliální růstový faktor A analýza   MeSH
• viabilita buněk MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Názvy látek
• glukosa MeSH
• vaskulární endoteliální růstový faktor A MeSH