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NCT04864834 · ClinicalTrials.gov registry record · Phase 3
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration
A Phase 3 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 485
- Enrollment target
NCT04864834 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 485 participants.
The verdict
NCT04864834, a Phase 3 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 485 participants
- Enrollment target
Study 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?
Interventions
- BIOLOGICAL SOK583A1 (40 mg/mL)
- BIOLOGICAL Eylea EU (40 mg/mL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2021-05-12 |
| Est. Completion | 2023-05-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04864834
The ClinicalTrials.gov registry entry for NCT04864834 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 485 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SOK583A1 (40 mg/mL) is the first listed.
NCT04864834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04864834 about?
NCT04864834 is a clinical study titled "Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration". 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 sco...
What is the current status of trial NCT04864834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2021-05-12. Estimated completion is 2023-05-10.
What interventions are being tested in trial NCT04864834?
The interventions under investigation include: SOK583A1 (40 mg/mL) (BIOLOGICAL), Eylea EU (40 mg/mL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04864834?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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