INTRODUCTION: AZURE was a 76-week, randomized, open-label, parallel-group, phase IIIb noninferiority study comparing the efficacy and safety of intravitreal aflibercept (IVT-AFL) in a treat-and-extend (T&E) regimen with fixed dosing in patients with neovascular age-related macular degeneration (nAMD) previously receiving IVT-AFL for ≥ 1 year. METHODS: Patients were aged ≥ 51 years and had completed ≥ 1 year of IVT-AFL treatment prior to enrollment (IVT-AFL once per month [- 1 or + 2 weeks] for 3 months followed by IVT-AFL every 2 months [6-12 weeks]). Patients were randomly assigned (1:1) to receive IVT-AFL 2 mg in either a T&E (minimum treatment interval of 8 weeks with no upper limit, adjusted according to functional and anatomic outcomes, as assessed by the investigator; n = 168), or a fixed dosing regimen (treatment every 8 weeks [± 3 days]; n = 168). The primary endpoint was best-corrected visual acuity (BCVA) change from baseline to week (W) 52. The key secondary endpoint was the proportion of patients maintaining vision (< 15-letter loss) at W52. RESULTS: The full analysis set comprised 332 patients (T&E: n = 165; fixed dosing: n = 167). Mean BCVA change (baseline to W52) was - 0.3 ± 7.5 vs. - 0.5 ± 8.4 letters (T&E vs. fixed dosing; least-squares mean difference [95% CI]: 0.22 [- 1.51 to 1.96] letters; P < 0.0001 for noninferiority test [5-letter margin]). From baseline to W52, 95.2% (T&E) and 94.0% (fixed dosing) of patients maintained vision. Mean central subfield thickness change from baseline to W52 was - 24 ± 55 (T&E) and - 33 ± 47 (fixed dosing) μm. Last treatment interval to W76 was ≥ 12 weeks for 37.0% of T&E patients. No new safety signals were identified. CONCLUSION: IVT-AFL T&E can achieve similar functional and anatomic outcomes to fixed dosing every 8 weeks over 52 weeks in patients with nAMD who have completed ≥ 1 year of treatment, while reducing treatment burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540954.

• MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace * farmakoterapie   MeSH
• receptory vaskulárního endoteliálního růstového faktoru * terapeutické užití   MeSH
• rekombinantní fúzní proteiny * terapeutické užití   MeSH
• senioři MeSH
• výsledek terapie MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• klinické zkoušky, fáze III MeSH
• randomizované kontrolované studie 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

Cíl: Cílem práce bylo zjistit hranice vzdálené nasální části zorného pole u pacientů s fyziologickým očním nálezem. Materiál a metody: Vyšetření zorného pole bylo provedeno u 15 zdravých osob (30 očí). U devíti žen ve věku 20–43 let a šesti mužů ve věku 22–35 let. U všech očí byl zjištěn fyziologický oční nález a zraková ostrost 1,0 s korekcí menší nebo rovnou 3 dioptrie. Zorné pole bylo vyšetřeno přístrojem Medmont M700 posunutím fixačního bodu o 40 stupňů temporálně a současného stočení hlavy nasálně, programem prostorové přizpůsobivosti. Celkem bylo zahrnuto 89 vyšetřovaných bodů pomocí flicker podnětů. Výsledky: Vzdálená nasální hranice zorného pole dosáhla u 13,3 % očí 100°, u 20 % očí 105° a u 66,7 % očí až 110°. Závěr: Hranice vzdálené nasální části zorného pole dosahovala 100–110 stupňů (při eliminaci stínění kořenem nosu).

Aims: The aim of the study was to determine the limits of the far nasal part of the visual field. Material and Methods: Visual field examination was performed in 15 healthy subjects (30 eyes), specifically nine women aged 20–43 years and six men aged 22–35 years. All eyes were found to have physiological ocular findings and visual acuity of 1.0 with correction less than or equal to 3 diopters. The visual field was examined with a Medmont M700 instrument by shifting the fixation point 40 degrees temporally and simultaneously turning the head nasally, with a spatial accommodation program. A total of 89 examination points were included using flicker stimuli. Results: The far nasal limit of the visual field reached 100° in 13.3% of eyes, 105° in 20% of eyes and up to 110° in 66.7% of eyes. Conclusion: The limit of the far nasal part of the field of vision reached 100–110 degrees (when nose shielding was eliminated).

• MeSH
• dospělí MeSH
• lidé MeSH
• testy zrakového pole metody   MeSH
• zraková ostrost MeSH
• zraková pole * fyziologie   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH

Cíl: Cílem této studie bylo ověřit možné změny konvenčně nediagnostikované nasální části zorného pole u pacientů s diagnózou včasného primárního glaukomu s otevřeným úhlem (PGOÚ) s vysokou tenzí. Materiál a metody: Vyšetření vzdálené nasální části zorného pole bylo provedeno u 30 nemocných (60 očí) s počínajícím PGOÚ (preperimetrické stadium změn). Soubor tvořilo 16 žen (průměrného věku 46,5 let) a 14 mužů (průměrného věku 44,7 let). U všech očí bylo zjištěno glaukomovým programem (rychlý prahový program v rozsahu 50 stupňů nasálně a 22 stupňů temporálně) přístrojem Medmont M700 fyziologické zorné pole. Zraková ostrost byla 1,0 s případnou korekcí menší nebo rovnou ±3 dioptrie, a kromě glaukomového onemocnění neměli jinou oční vadu. Zorné pole bylo následně vyšetřeno stejným přístrojem posunutím fixačního bodu o 40 stupňů temporálně (prostorově adaptabilní program) a současným otočením hlavy o 10 stupňů nasálně. Celkem bylo zahrnuto 89 vyšetřovacích bodů s použitím flicker podnětů a rozsahem 0–120 stupňů nasálně. Výsledky: U všech očí byla zjištěna deprese vzdálené periferie nasální části zorného pole v rozsahu od 50 do 95 stupňů, při normální zorném poli vyšetřeným glaukomovým programem. Závěr: Při normálním zorném poli vyšetřeném rychlým prahovým glaukomovým programem byly u všech nemocných PGOÚ zjištěny změny v distální části nasální periferie zorného pole.

Aim: The aim of this study was to examine possible changes in the conventionally undiagnosed nasal visual field in patients diagnosed with early primary open angle glaucoma. Material and Methods: Examination of the far nasal part of the visual field was performed in 30 patients (60 eyes) with early stage of primary open angle glaucoma (preperimetric stage of changes). The cohort consisted of 16 women (mean age 46.5 years) and 14 men (mean age 44.7 years). In all eyes, the glaucoma program (rapid threshold program of 50 degrees nasally and 22 degrees temporally) was performed with the Medmont M700 instrument to determine the physiological visual field. Visual acuity was 1.0 with a possible correction less than or equal to ±3 diopters and they had no other ocular defect except glaucoma disease. The visual field was subsequently examined with the same instrument by moving the fixation point 40 degrees temporally (spatially adaptive program) and simultaneously turning the head 10 degrees nasally. A total of 89 examination points were included using flicker stimuli and a range of 0–120 degrees nasally. Results: The far nasal limit of the visual field reached 100° in 13.33% of eyes, 105° in 20% of eyes and up to 110° in 66.67% of eyes. Conclusion: In all eyes, depression of the distal periphery of the nasal part of the visual field was found to range from 50 to 95 degrees, with a normal visual field examined by the glaucoma program.

• MeSH
• časná diagnóza MeSH
• glaukom s otevřeným úhlem diagnóza   MeSH
• glaukom * diagnóza   MeSH
• lidé MeSH
• optická koherentní tomografie MeSH
• testy zrakového pole metody   MeSH
• zraková pole MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• klinická studie MeSH

Refractive surgery with excimer laser has been a very common surgical procedure worldwide during the last decades. Currently, patients who underwent refractive surgery years ago are older, with a growing number of them now needing cataract surgery. To establish the power of the intraocular lens to be implanted in these patients, it is essential to define the true corneal power. However, since the refractive surgery modified the anterior, but not the posterior surface of the cornea, the determination of the corneal power in this group of patients is challenging. This article reviews the different sources of error in finding the true corneal power in these cases, and comments on several approaches, including the clinical history method as described originally by Holladay, and a modified version of it, as well as new alternatives based on corneal tomography, using devices that are able to measure the actual anterior and posterior corneal curvatures, which have emerged in recent years to address this issue.

• MeSH
• laserová modelace rohovky pod rohovkovou lamelou * MeSH
• lasery excimerové MeSH
• lidé MeSH
• refrakce oka * MeSH
• rohovka chirurgie   MeSH
• rohovková topografie metody   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH

• MeSH
• diagnostické techniky oftalmologické MeSH
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• novorozenec MeSH
• oční nemoci * diagnóza   prevence a kontrola   MeSH
• předškolní dítě MeSH
• primární prevence MeSH
• zrak fyziologie   MeSH
• zrakové testy MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• novorozenec MeSH
• předškolní dítě MeSH
• Publikační typ
• směrnice pro lékařskou praxi MeSH

• MeSH
• diferenciální diagnóza MeSH
• lidé MeSH
• nemoci zrakového nervu * diagnostické zobrazování   diagnóza   terapie   MeSH
• poruchy hybnosti oka diagnóza   MeSH
• roztroušená skleróza * komplikace   terapie   MeSH
• testy zrakového pole MeSH
• uveitida diagnóza   terapie   MeSH
• zánět zrakového nervu diagnostické zobrazování   diagnóza   terapie   MeSH
• zraková ostrost 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

Aims: We present two rare cases of non-surgical-related massive spontaneous suprachoroidal hemorrhage. Case report: The first case was a 73-year-old male with uncontrolled hypertension, who presented with left vision loss, only able to perceive light, with very high intraocular pressure (IOP) and blood pressure (BP), 68 mmHg and 196/106 mmHg, respectively. Ocular examination showed a limited fundus view, and the B-scan revealed near kissing suprachoroidal hemorrhage. The second case was a 59-year-old male, post valve replacement surgery on life-long warfarin, who presented with hand movement vision and IOP of 47 mmHg. The B-scan showed massive submacular and suprachoroidal hemorrhage with therapeutic range International Normalized Ratio (INR). Conclusion: Suprachoroidal hemorrhage is one of the rare complications that can be seen in any ocular surgery. However, spontaneous suprachoroidal hemorrhage is a rarer disease. Most of the reported cases are associated with underlying medical conditions. Thus prevention is crucial. This involves ophthalmologists, physicians and general practitioners in managing this group of patients with associated risk factors, for better recognition of this devastating ocular complication in which early detection may reduce ocular morbidity.

• Klíčová slova
• spontánní subarachnoidální krvácení,
• MeSH
• acetazolamid aplikace a dávkování   terapeutické užití   MeSH
• antihypertenziva aplikace a dávkování   terapeutické užití   MeSH
• choroidální krvácení * diagnóza   farmakoterapie   MeSH
• glycerol aplikace a dávkování   terapeutické užití   MeSH
• latanoprost aplikace a dávkování   terapeutické užití   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nitrooční tlak účinky léků   MeSH
• senioři MeSH
• výsledek terapie MeSH
• zraková ostrost fyziologie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• kazuistiky MeSH