Trials / Completed
CompletedNCT04864834
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration
A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 485 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?
Detailed description
BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SOK583A1 (40 mg/mL) | IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. |
| BIOLOGICAL | Eylea EU (40 mg/mL) | IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. |
Timeline
- Start date
- 2021-05-12
- Primary completion
- 2022-07-07
- Completion
- 2023-05-10
- First posted
- 2021-04-29
- Last updated
- 2024-03-26
- Results posted
- 2024-03-26
Locations
102 sites across 16 countries: United States, Australia, Austria, Bulgaria, Czechia, France, Germany, Hungary, Israel, Japan, Latvia, Lithuania, Poland, Portugal, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04864834. Inclusion in this directory is not an endorsement.