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NCT05989126 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT05989126: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT05989126 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05989126, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial. This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD). The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.
Primary Outcome
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
Interventions
- DRUG aflibercept 8 mg PFS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-04-15 |
| Est. Completion | 2024-05-31 |
| Phase | Phase 3 |
What the finished NCT05989126 record still lists
NCT05989126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which aflibercept 8 mg PFS is the first listed.
NCT05989126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05989126 about?
NCT05989126 is a clinical study titled "Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)". Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the...
What is the current status of trial NCT05989126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2024-04-15. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT05989126?
The interventions under investigation include: aflibercept 8 mg PFS (DRUG).
Who is sponsoring clinical trial NCT05989126?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05989126's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 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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