Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT03767738
- Phase
- PHASE4
- Status
- Completed
Conditions
- Chorioretinal Vascular Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intravitreal Aflibercept Injection (IAI) — DRUGIAI prepared and administered with a pre-filled syringe (PFS)
Study Details
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection. The secondary objective of the study is to assess ocular safety in the study eye.
Key Dates
- Start date
- Dec 19, 2018
- Status verified
- Aug 2021
- Primary completion
- Aug 19, 2020
- Completion
- Aug 19, 2020
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intravitreal Aflibercept Injection (IAI)Cohort 1 - Initial patients Cohort 2 - Additional patients
Primary Outcome Measure
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) [ Time Frame: At Day 1 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Regeneron Study Site | Houston | Texas | 77030 | - |
| Regeneron Study Site | The Woodlands | Texas | 77384 | - |