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 (Mylight)
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- STATUS
- Recruiting
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- days left to enroll
- 49
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- participants needed
- 460
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- sponsor
- Sandoz
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?
Description
BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor
Details
| Condition | Neovascular Age-related Macular Degeneration |
|---|---|
| Treatment | SOK583A1 (40 mg/mL), Eylea EU (40 mg/mL) |
| Clinical Study Identifier | NCT04864834 |
| Sponsor | Sandoz |
| Last Modified on | 24 October 2022 |
Eligibility
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