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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
IVT injection
IVT injection
Retina Consultants of Texas - Austin Retina
Austin, Texas, United States
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 - The Woodlands Retina Center
The Woodlands, Texas, United States
Percentage of IVT Injections Successfully Administered
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.
Time frame: Day of IVT injection (study day 1)
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye
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 5.0
Time frame: Up to 28 days
Number of Participants With Serious Ocular TEAEs in Study Eye
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
Time frame: Up to 28 days
Number of Participants With Non-ocular Serious TEAEs
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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
Time frame: Up to 28 days