A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
Part of paid clinical trials in Austin, Texas.
- Sponsor
- Amgen
- Study ID
- NCT05704725
- Phase
- PHASE3
- Status
- Completed
Conditions
- Chorioretinal Vascular Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- ABP 938 — DRUGIVT injection
- Aflibercept — DRUGIVT injection
Study Details
The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS.
Key Dates
- Start date
- Jan 23, 2023
- Status verified
- Feb 2025
- Primary completion
- Feb 17, 2023
- Completion
- Mar 24, 2023
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ABP 938Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
- Experimental: AfliberceptParticipants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
Primary Outcome Measure
Percentage of IVT Injections Successfully Administered [ Time Frame: Day of IVT injection (study day 1) ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Retina Consultants of Texas - Austin Retina | Austin | Texas | 78705 | - |
| Retina Consultants of Texas - Bellaire Retina Center | Bellaire | Texas | 77401 | - |
| Retinal Consultants of Texas - San Antonio Retina Center | San Antonio | Texas | 78240-1657 | - |
| Retina Consultants of Texas - The Woodlands Retina Center | The Woodlands | Texas | 77384 | - |