An Open Label, Two-Arm Study in Subjects With Chorioretinal Vascular Disease to Evaluate ABP 938 and Aflibercept (Eylea®) in a Prefilled Syringe
Overview
- Phase
- Phase 3
- Intervention
- ABP 938
- Conditions
- Chorioretinal Vascular Disease
- Sponsor
- Amgen
- Enrollment
- 49
- Locations
- 4
- Primary Endpoint
- Percentage of IVT Injections Successfully Administered
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABP 938
Participants 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.
Intervention: ABP 938
Aflibercept
Participants 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.
Intervention: Aflibercept
Outcomes
Primary Outcomes
Percentage of IVT Injections Successfully Administered
Time Frame: Day of IVT injection (study day 1)
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
Secondary Outcomes
- Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye(Up to 28 days)
- Number of Participants With Serious Ocular TEAEs in Study Eye(Up to 28 days)
- Number of Participants With Non-ocular Serious TEAEs(Up to 28 days)