A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
- Registration Number
- NCT05704725
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABP 938 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. Aflibercept 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.
- Primary Outcome Measures
Name Time Method Percentage of IVT Injections Successfully Administered 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 Outcome Measures
Name Time Method Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye Up to 28 days An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. Events that met the AE definition are as follows:
* Any abnormal or worsening ocular safety result that is considered clinically significant in the medical and scientific judgment of the investigator.
* Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
* New conditions detected or diagnosed after study treatment administration even though it may have been present before the start of the study.
* Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a concomitant medication.
AEs were classified by system organ class (SOC) according to the Medical Dictionary for Regulatory Activities (medDRA) and graded by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0Number of Participants With Serious Ocular TEAEs in Study Eye Up to 28 days A serious AE is any event that met at least 1 of the following serious criteria:
* Fatal.
* Life-threatening (places the participant at immediate risk of death).
* Requires inpatient hospitalization or prolongation of existing hospitalization.
* Results in persistent or significant disability/incapacity.
* Congenital anomaly/birth defect.
* Other medically important serious event.
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0Number of Participants With Non-ocular Serious TEAEs Up to 28 days A serious AE is any event that met at least 1 of the following serious criteria:
* Fatal.
* Life-threatening (places the participant at immediate risk of death).
* Requires inpatient hospitalization or prolongation of existing hospitalization.
* Results in persistent or significant disability/incapacity.
* Congenital anomaly/birth defect.
* Other medically important serious event.
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0
Trial Locations
- Locations (4)
Retina Consultants of Texas - Bellaire Retina Center
🇺🇸Bellaire, Texas, United States
Retinal Consultants of Texas - San Antonio Retina Center
🇺🇸San Antonio, Texas, United States
Retina Consultants of Texas - Austin Retina
🇺🇸Austin, Texas, United States
Retina Consultants of Texas - The Woodlands Retina Center
🇺🇸The Woodlands, Texas, United States