Age-related macular degeneration (AMD) is a progressive chronic disease causing visual impairment or central vision loss in the elderly. We hypothesized that successful rheopheresis would be associated with positive changes in soluble endoglin (sENG), PSCK9, alpha-2-macroglobulin (A2M), and hs-CRP levels. 31 elderly patients with the dry form of AMD, treated with rheopheresis with a follow-up period of at least 5 years and an average age of 68 ± 4 years, were evaluated. Each treated patient received a series of 8 procedures in 10 weeks and, after the 2-year period, another 2 procedures within 1 week. Then, the patients were followed up every 6 months and divided into the successfully treated and therapeutic failure group according to best-corrected visual acuity (BCVA), size of the drusen area, and the drusenoid pigment epithelium detachment (DPED). Based on the ophthalmological assessment, rheopheresis treatment was successful in 73% of AMD patients. The therapy was associated with a significant decrease in total cholesterol, LDL-C, HDL-C, apoprotein B, lipoprotein (a) levels, and rheologically important parameters, irrespective of the therapy's success or failure. The success of rheopheresis therapy was exclusively related to a significant decrease in sENG and A2M levels. Over the long term, rheopheresis prevented the decline of BCVA, reduced the DPED and area of macular drusen, and improved the preservation of an intact photoreceptor ellipsoid zone in most patients. Moreover, we showed for the first time that sENG and A2M could be potentially sensitive biomarkers of successful rheopheresis procedure, irrespective of lipid parameters changes.

• MeSH
• biologické markery * krev   MeSH
• endoglin * krev   MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace * terapie   krev   MeSH
• senioři MeSH
• výsledek terapie MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND/AIMS: To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD). DESIGN: Prospective, double-masked, randomised, phase 3 trial. METHODS: Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch's membrane). Additional endpoints included safety, PK and immunogenicity. RESULTS: Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (-2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were -119.2 μm and -132.4 μm for SB15/SB15 and -126.6 μm and -136.3 μm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 μm (-6.11 to 20.96); TRT: difference (95% CI)=3.9 μm (-18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (-2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups. CONCLUSIONS: Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

• MeSH
• biosimilární léčivé přípravky * terapeutické užití   MeSH
• inhibitory angiogeneze terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé MeSH
• makulární degenerace * farmakoterapie   MeSH
• prospektivní studie MeSH
• zraková ostrost MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

Diabetický makulární edém (DME) patří společně s diabetickou retinopatií mezi hlavní příčiny těžké ztráty zraku u produktivní populace. V nedávných letech byly zlepšeny diagnostické možnosti díky rozvoji zobrazovacích metod, což umožnilo vytvořit nová klasifikační schémata DME. Dále byly představeny nové možnosti léčby – jak nové léčivé přípravky podávané do sklivce, tak inovace v dávkovacích schématech jejich podání. Zároveň je stále dostupná laserová, chirurgická a také kombinovaná léčba. V práci jsou vyhodnoceny a shrnuty současné poznatky o dostupných diagnostických a léčebných metodách DME a na jejich základě jsou formulovány doporučené postupy diagnostiky, klasifikace a léčby DME.

Together with diabetic retinopathy, diabetic macular edema (DME) ranks among the most common causes of severe loss of vision in working adults. Due to recent developments in imaging methods, new classification schemes of DME have been created. In addition to this, new treatment options have been introduced (new intravitreal drugs as well as treatment protocols). At the same time laser, surgical as well as combination therapy is still available. In this paper we evaluate the current knowledge about DME diagnostic and treatment options and formulate recommended guidelines for the management of DME.

• Klíčová slova
• diabetický makulární edém,
• MeSH
• diabetická retinopatie komplikace   MeSH
• komplikace diabetu MeSH
• lidé MeSH
• makulární edém * diagnóza   terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• směrnice pro lékařskou praxi MeSH

Diabetická retinopatie je jednou z nejčastějších komplikací cukrovky a představuje tak závažný zdravotní, sociální i ekonomický problém. S očekávaným nárůstem počtu diabetiků se tak stává hlavní příčinou závažné ztráty zraku populace produktivního věku. Předkládané doporučené postupy přehledně shrnují současné poznatky o tomto onemocnění s cílem sjednotit a aktualizovat postupy při diagnostice, klasifikaci a léčbě diabetické retinopatie.

Diabetic retinopathy is one of the most common complications of diabetes mellitus and represents a serious health, social and economic problem. With the expected increase in the number of patients with diabetes, it is becoming the leading cause of severe vision loss in the working-age population. The presented guidelines summarize the current knowledge about this disease in order to standardize and update the procedures for the diagnosis, classification and treatment of diabetic retinopathy

• MeSH
• diabetická retinopatie * diagnóza   terapie   MeSH
• komplikace diabetu MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• směrnice pro lékařskou praxi MeSH

Diabetická retinopatie (DR) a diabetický makulární edém (DME) patří mezi nejčastější příčiny ztráty zraku u pracující populace a mají tak významný zdravotní i socioekonomický dopad, který se navíc vzhledem k epidemiologickým predikcím bude v nejbližších letech zvětšovat. Zásadní roli pro řešení DR a DME nejen pro jednotlivé nemocné, ale především pro populaci má kvalitní screeningový program. Ten je podmíněn strukturou a organizací zdravotní péče, posledními vědeckými poznatky v diagnostice (zobrazovací metody), technologickými novinkami ve výpočetní technice (umělá inteligence, telemedicína) a jejich praktickým uplatněním, dále doporučením Světové zdravotnické organizace. V práci jsou zhodnoceny všechny tyto faktory včetně medicíny založené na důkazech a zkušenostech ze zahraničí u srovnatelných zemí. Na základě vyhodnocení těchto parametrů byly formulovány doporučené postupy pro screening závažných očních komplikací diabetu – DR a DME – včetně návaznosti na Národní screeningové centrum a organizaci zdravotní péče v ČR.

Diabetic retinopathy (DR) and diabetic macular edema (DME) are leading causes of severe visual loss in the working population. Therefore, both DR and DME have a significant socioeconomic and health impact, which taking into account the epidemiologic predictions is expected to increase. A crucial role in the management of DR and DME (not only for individuals, but also for the population) is played by an adequate screening program. This is based on the structure and organization of the healthcare system, the latest scientific developments in diagnostics (imaging) as well as technological advancements in computing (artificial intelligence, telemedicine) and their practical use. The recommendation presented by World Health Organization is also important. This paper evaluates all these factors, including evidence-based medicine reports and experience from existing DR and DME screening programs in comparable countries. Based on an evaluation of these parameters, recommended guidelines have been formulated for screening for DR and DME in the Czech Republic, including linkage to the Czech National Screening Center and the organization of the healthcare system.

• MeSH
• diabetická retinopatie * diagnóza   MeSH
• lidé MeSH
• makulární edém * diagnóza   MeSH
• screeningové diagnostické programy MeSH
• směrnice pro lékařskou praxi jako téma MeSH
• Check Tag
• lidé MeSH

BACKGROUND/AIMS: To provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD). METHODS: Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one 'study eye'. INTERVENTION: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks. RESULTS: Baseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was -0.6 letters (90% CI -2.1 to 0.9) and of change from baseline in central subfield thickness was -14.9 μm (95% CI -25.3 to -4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively. CONCLUSIONS: Longer-term results of this study further support the biosimilarity established between SB11 and RBZ.

• MeSH
• biosimilární léčivé přípravky * terapeutické užití   MeSH
• inhibitory angiogeneze terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace * farmakoterapie   MeSH
• ranibizumab terapeutické užití   MeSH
• vaskulární endoteliální růstový faktor A MeSH
• vlhká makulární degenerace * diagnóza   farmakoterapie   MeSH
• výsledek terapie MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

IMPORTANCE: Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy. OBJECTIVE: To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD). DESIGN, SETTING, AND PARTICIPANTS: This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up. INTERVENTION: Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56. MAIN OUTCOMES AND MEASURES: The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of -3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity. RESULTS: The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, -110.4 μm vs AFL, -115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable. CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04450329.

• MeSH
• biosimilární léčivé přípravky * škodlivé účinky   MeSH
• inhibitory angiogeneze škodlivé účinky   MeSH
• injekce intravitreální MeSH
• lidé MeSH
• makulární degenerace * farmakoterapie   MeSH
• ranibizumab terapeutické užití   MeSH
• receptory vaskulárního endoteliálního růstového faktoru terapeutické užití   MeSH
• rekombinantní fúzní proteiny škodlivé účinky   MeSH
• senioři MeSH
• vlhká makulární degenerace * diagnóza   farmakoterapie   chemicky indukované   MeSH
• výsledek terapie MeSH
• zraková ostrost MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Monografie zkušeného autorského kolektivu předkládá v kompletním a v českém písemnictví dosud nevídaném rozsahu informace o sítnici a jejích chorobách, které jsou využitelné jak očními lékaři, kteří pracují v nemocnicích a ambulancích, tak lékaři pracujícími na vědeckých úkolech.

• Klíčová slova
• Oftalmologie, ORL,
• MeSH
• nemoci retiny MeSH
• oftalmologické chirurgické výkony MeSH
• retina MeSH

• NLK Obory
• anatomie
• oftalmologie

Přehled, který se zaměřuje na anatomii sítnice a nemoci sítnice, včetně jejich léčby. Určeno odborné veřejnosti.

• MeSH
• nemoci retiny MeSH
• oftalmologické chirurgické výkony MeSH
• retina MeSH
• Publikační typ
• přehledy MeSH

• Konspekt
• Ortopedie. Chirurgie. Oftalmologie
• NLK Obory
• anatomie
• oftalmologie
• NLK Publikační typ
• kolektivní monografie