Publications by authors named "Jan Ernest"
Retinal vein occlusion and its complications are among the most common causes of severe loss of sight in developed countries. In recent years, developments in imaging methods have been introduced, leading to an improvement in diagnostic possibilities. At the same time new treatment options have become available (new intravitreal drugs and treatment protocols, laser and surgical methods).
View Article and Find Full Text PDFImportance: 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.
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).
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).
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.
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.
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: : Multicentre. : Randomised, double-masked, parallel-group, phase III equivalence study.
Importance: Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment.
Objective: To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab.
Purpose: To evaluate the effect of intravitreal aflibercept injections in treatment-naive type 3 neovascularization using a fixed treatment regime during the first year of therapy.
Methods: Fourteen eyes of 14 patients diagnosed with type 3 neovascularization were studied. All patients were treated with intravitreal aflibercept injections using a fixed treatment regime of 3 consecutive monthly dosages followed by 2-month interval injections.
Background: Despite the significant impact of retinal diseases such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), there is a limited understanding of how these conditions are managed in Central and Eastern Europe (CEE).
Objectives: To provide a comprehensive overview of the clinical and economic burden of wAMD and DME in CEE and the status quo associated with their management.
Methods: A narrative literature review was undertaken to identify existing data on wAMD and DME, including epidemiology, economic burden, clinical guidelines, and available and reimbursed treatments.
Purpose: To report a case of a 29-year-old man who was examined at the Eye Clinic of Central Military University Hospital Prague for a severe headache and acute blurring of vision in both eyes diagnosed as incomplete Vogt-Koyanagi-Harada syndrome (VKH).
Methods: This is a retrospective and descriptive case report based on data from clinical records, patient observation and follow-ups and analysis of acquired diagnostic tests.
Results: A 29-year-old man presented with headache and decreased vision in his left eye (LE) for 2 days.
Purpose: To determine the safety and efficacy of low-voltage, external-beam, stereotactic radiotherapy (SRT) for patients with neovascular age-related macular degeneration (nvAMD).
Design: Randomized, double-masked, sham-controlled, multicenter, clinical trial.
Participants: Two hundred thirty patients with onset of nvAMD within 3 years who received 3 or more injections of ranibizumab or bevacizumab within the preceding year and who needed continuing ranibizumab or bevacizumab treatment.