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NCT05161806 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
A Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT05161806: Completed Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by Sandoz.
NCT05161806 is a Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD) that has completed, run by Sandoz. The registered enrollment target is 30 participants, below the 205-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05161806, a Phase 3 study of Neovascular Age-related Macular Degeneration (nAMD), has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Primary Outcome
Number of participants with ocular treatment emergent adverse events were reported.
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 |
What the finished NCT05161806 record still lists
NCT05161806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 205-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (85% lower).
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.
NCT05161806 reports a single indexed study location in Georgia, Illinois, New York.
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).
What interventions are being tested in trial NCT05161806?
The interventions under investigation include: SOK583A1 (40 mg/mL) (DRUG), Prefilled Syringe (PFS) (DEVICE).
Who is sponsoring clinical trial NCT05161806?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Neovascular Age-related Macular Degeneration (nAMD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05161806's enrollment target sits among peer trials
30 9th of 9 higher than 1 of 9 other Neovascular Age-related Macular Degeneration (nAMD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration (nAMD) 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.
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