Publications by authors named "Ernest Jan"
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).
Article Synopsis
- Aflibercept biosimilars like SB15 can enhance treatment options for retinal diseases, potentially increasing patient access to effective therapies.
- A phase 3 trial was conducted with 449 participants aged 50 and older with neovascular age-related macular degeneration to compare the efficacy and safety of SB15 and the reference drug, Aflibercept (AFL).
- The results showed that SB15 produced comparable improvements in visual acuity as AFL after 8 weeks, indicating equivalence in efficacy between the two treatments.
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.
Article Synopsis
- This study aimed to evaluate the long-term efficacy, safety, immunogenicity, and pharmacokinetics of the ranibizumab biosimilar SB11 compared to the original ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).
- Conducted as a multicenter, randomized, double-masked, parallel-group phase III equivalence trial with 705 participants, the study involved monthly intravitreal injections of either SB11 or RBZ and followed participants for 52 weeks.
- Results showed comparable visual outcomes, safety profiles, and immune responses between SB11 and RBZ, confirming that SB11 is a suitable alternative to RBZ in treating nAMD.
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.