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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: Completed Phase 3 study, sponsored by Sandoz.
NCT04864834 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 485 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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?
Primary Outcome
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
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 |
What the finished NCT04864834 record still lists
NCT04864834 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which SOK583A1 (40 mg/mL) is the first listed.
NCT04864834 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04864834's enrollment target sits among peer trials
485 790th of 2000 higher than 1,210 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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