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Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
NCT05161806 · View on ClinicalTrials.gov ↗
Study Summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Conditions Studied
Interventions
- DRUG SOK583A1 (40 mg/mL)
- DEVICE Prefilled Syringe (PFS)
Study Locations (3)
Georgia
- Sandoz Investigational Site — Marietta
Illinois
- Sandoz Investigational Site — Oak Forest
New York
- Sandoz Investigational Site — Liverpool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2022-05-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05161806
The ClinicalTrials.gov registry entry for NCT05161806 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neovascular Age-related Macular Degeneration (nAMD) appearing as the primary indexed condition, and to 2 interventions — of which SOK583A1 (40 mg/mL) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05161806 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05161806 about?
NCT05161806 is a clinical study titled "Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe". This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
What is the current status of trial NCT05161806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2022-03-11. Estimated completion is 2022-05-04.
What conditions does trial NCT05161806 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration (nAMD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05161806?
The interventions under investigation include: SOK583A1 (40 mg/mL) (DRUG), Prefilled Syringe (PFS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05161806?
This trial is sponsored by Sandoz, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05161806 being conducted?
This trial has 3 study locations across Georgia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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