IMPORTANCE: Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME). OBJECTIVE: To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME. DESIGN, SETTING, AND PARTICIPANTS: This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021. INTERVENTIONS: Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52. MAIN OUTCOMES AND MEASURES: The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of -3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs). RESULTS: A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, -1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was -112 (7) μm vs -124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, -3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms. CONCLUSIONS AND RELEVANCE: MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03610646.
- MeSH
- biosimilární léčivé přípravky * terapeutické užití škodlivé účinky MeSH
- diabetická retinopatie * farmakoterapie diagnóza patofyziologie MeSH
- dvojitá slepá metoda MeSH
- inhibitory angiogeneze * aplikace a dávkování terapeutické užití škodlivé účinky MeSH
- injekce intravitreální * MeSH
- lidé středního věku MeSH
- lidé MeSH
- makulární edém * farmakoterapie patofyziologie diagnóza MeSH
- optická koherentní tomografie MeSH
- receptory vaskulárního endoteliálního růstového faktoru * aplikace a dávkování MeSH
- rekombinantní fúzní proteiny * terapeutické užití aplikace a dávkování MeSH
- senioři MeSH
- vaskulární endoteliální růstový faktor A antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- zraková ostrost * fyziologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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
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.
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
OBJECTIVE: To evaluate the efficacy, safety, and immunogenicity of a ranibizumab biosimilar candidate (XSB-001) versus reference product (Lucentis) for neovascular age-related macular degeneration (nAMD). DESIGN: Phase III, multicenter, randomized, double-masked, parallel-group study. PARTICIPANTS: Patients with nAMD. METHODS: Eligible patients were randomized (1:1) to receive intravitreal injections of XSB-001 or reference ranibizumab (0.5 mg [0.05 ml]) in the study eye once every 4 weeks for 52 weeks. Efficacy and safety assessments continued through 52 weeks of treatment. MAIN OUTCOME MEASURES: Primary end point was change from baseline in best-corrected visual acuity (BCVA) by ETDRS letters at week 8. Biosimilarity was concluded if the 2-sided 90% confidence interval (CI) (United States) or 95% CI (rest of world) for the difference in least-squares (LS) mean change in BCVA at week 8 between treatment groups was within the predefined equivalence margin of ± 3.5 letters. RESULTS: In total, 582 patients (n = 292 XSB-001, n = 290 reference ranibizumab) were randomized. Mean age was 74.1 years, most patients (85.2%) were White, and 55.8% were women. Mean BCVA score at baseline was 61.7 and 61.5 ETDRS letters in the XSB-001 and reference ranibizumab groups, respectively. At week 8, the LS mean (standard error [SE]) change in BCVA from baseline was 4.6 (0.5) ETDRS letters in the XSB-001 group and 6.4 (0.5) letters in the reference ranibizumab group (LS mean [SE] treatment difference: -1.8 [0.7] ETDRS letters; 90% CI, -2.9 to -0.7; 95% CI, -3.1 to -0.5). The 90% CI and 95% CI for LS mean difference in change from baseline were within the predefined equivalence margin. At week 52, LS mean (SE) change in BCVA was 6.4 (0.8) and 7.8 (0.8) letters, respectively (LS mean [SE] treatment difference, -1.5 [1.1] ETDRS letters; 90% CI, -3.3 to 0.4; 95% CI, -3.6 to 0.7). There were no clinically meaningful differences between treatments in anatomical, safety, or immunogenicity end points through week 52. CONCLUSIONS: XSB-001 demonstrated biosimilarity to reference ranibizumab in patients with nAMD. Treatment with XSB-001 for 52 weeks was generally safe and well tolerated, with a safety profile similar to the reference product. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
- MeSH
- biosimilární léčivé přípravky * terapeutické užití MeSH
- inhibitory angiogeneze MeSH
- lidé MeSH
- makulární degenerace * diagnóza farmakoterapie chemicky indukované MeSH
- ranibizumab MeSH
- senioři MeSH
- zraková ostrost MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Cíl: Analýza přítomnosti choroidální neovaskularizace (CNV) pomocí optické koherenční tomografické angiografie (OCTA) u očí léčených fotodynamickou terapií v redukovaném dávkovacím režimu (HD-PDT, poloviční dávka verteporfinu) pro chronickou formu centrální serózní chorioretinopatie (cCSC). Metodika a soubor: Retrospektivní zhodnocení OCTA nálezů 54 očí 52 pacientů léčených pro cCSC pomocí HD-PDT. Vyšetření OCTA bylo provedeno na přístroji Angioplex Zeiss Cirrus 5000 (Carl Zeiss Meditec, Dublin, CA, USA) 1 rok po provedení HD-PDT k verifikaci změn typických pro cCSC. Analýzou výsledků tohoto vyšetření jsme hodnotili zejména přítomnost či nepřítomnost konkomitující CNV a korelaci přítomné CNV s průměrnou výslednou nejlépe korigovanou zrakovou ostrostí (NKZO). Výsledky: Analyzovali jsme OCTA nálezy 54 očí (52 pacientů), u nichž jsme v případě 19 očí prokázali přítomnost konkomitující CNV (35,2 %). Prokázaná CNV se v 82 % vyskytovala pod undulující hyperreflexivní linií RPE. U očí s výskytem CNV byla průměrná NKZO (72 písmen ETDRS) statisticky signifikantně nižší než u pacientů bez CNV (82,7 písmen ETDRS) (p = 0,0179). Závěr: V našem retrospektivním hodnocení souboru pacientů, kteří podstoupili HD-PDT pro cCSC, jsme 1 rok po léčbě prokázali pomocí OCTA přítomnou CNV v 35,2 %. Domníváme se, že přítomná CNV typu I je spíše komplikací samotného chronického onemocnění než nežádoucím účinkem HD-PDT.
Purpose: Analysis of the presence of choroidal neovascularization (CNV) by optical coherence tomography angiography (OCTA) in eyes treated with photodynamic therapy in a reduced dosing regimen (HD-PDT, half dose of verteporfin) for the chronic form of central serous chorioretinopathy (cCSC). Materials and methods: Retrospective evaluation of OCTA findings in 54 eyes of 52 patients treated for cCSC with HD-PDT. OCTA was performed on Angioplex Zeiss Cirrus 5000 (Carl Zeiss Meditec, Dublin, CA, USA) 1 year after HD-PDT to verify changes typical of cCSC. By analyzing the results of this examination, we evaluated in particular the presence or absence of concomitant CNV and the correlation of the present CNV with the average resulting best corrected visual acuity (BCVA). Results: We analyzed the OCTA findings of 54 eyes (52 patients), in which we demonstrated the presence of concomitant CNV in 35 eyes (35.2 %). Revealed CNV occurred in 82 % below the undulating hyperreflective RPE line. In eyes with CNV, the mean BCVA (72 letters ETDRS) was statistically significantly lower than in eyes without CNV (82.7 letters ETDRS) (p = 0.0179). Conclusion: In our retrospective evaluation of a group of patients who underwent HD-PDT for cCSC, we demonstrated with OCTA the presence of CNV in 35.2 % eyes 1 year after the treatment. We believe that the presence of type I CNV is a complication of the chronic disease itself rather than an adverse effect of HD-PDT.
