Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration
Public ClinicalTrials.gov record NCT04864834. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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?
Study identification
- NCT ID
- NCT04864834
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 12, 2021 (Actual)
- Primary completion
- Jul 7, 2022 (Actual)
- Completion
- May 10, 2023 (Actual)
- Last update posted
- Mar 26, 2024
2021 – 2023
United States locations
- U.S. sites
- 28
- U.S. states
- 12
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sandoz Investigational Site | Phoenix | Arizona | 85021 | — |
| Sandoz Investigational Site | Arcadia | California | 91006 | — |
| Sandoz Investigational Site | Campbell | California | 95008 | — |
| Sandoz Investigational Site | Encino | California | 91436 | — |
| Sandoz Investigational Site | Fullerton | California | 92835 | — |
| Sandoz Investigational Site | Glendale | California | 91203 | — |
| Sandoz Investigational Site | Huntington Beach | California | 92647 | — |
| Sandoz Investigational Site | Pasadena | California | 91107 | — |
| Sandoz Investigational Site | Poway | California | 92064 | — |
| Sandoz Investigational Site | Redlands | California | 92374 | — |
| Sandoz Investigational Site | Sacramento | California | 95841 | — |
| Sandoz Investigational Site | Fort Myers | Florida | 33912-7125 | — |
| Sandoz Investigational Site | Pinellas Park | Florida | 33782 | — |
| Sandoz Investigational Site | Plantation | Florida | 33324 | — |
| Sandoz Investigational Site | Stuart | Florida | 34994 | — |
| Sandoz Investigational Site | Marietta | Georgia | 30060 | — |
| Sandoz Investigational Site | Oak Forest | Illinois | 60452 | — |
| Sandoz Investigational Site | Hagerstown | Maryland | 21740 | — |
| Sandoz Investigational Site | Albuquerque | New Mexico | 87102 | — |
| Sandoz Investigational Site | Great Neck | New York | 11021 | — |
| Sandoz Investigational Site | Liverpool | New York | 13088 | — |
| Sandoz Investigational Site | Rochester | New York | 14620 | — |
| Sandoz Investigational Site | Eugene | Oregon | 97401 | — |
| Sandoz Investigational Site | Rapid City | South Dakota | 57701 | — |
| Sandoz Investigational Site | Abilene | Texas | 79606 | — |
| Sandoz Investigational Site | Arlington | Texas | 76012 | — |
| Sandoz Investigational Site | Willow Park | Texas | 76087 | — |
| Sandoz Investigational Site | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04864834, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2024 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04864834 live on ClinicalTrials.gov.