A Phase 3 interventional study of ABP 938 and Aflibercept in Chorioretinal Vascular Disease, sponsored by Amgen. Completed at 4 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's enrollment of 49 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
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Exclusion Criteria
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.
Drug: 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.
Drug: Aflibercept
IVT injection
Also known as: PAVBLU™
IVT injection
Also known as: Eylea®
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
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
This study was conducted at 4 centers in the United States between 23 January 2023 and 24 March 2023.
| Milestone | ABP 938 | Aflibercept |
|---|---|---|
| Started | 33 | 16 |
| Completed | 32 | 15 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Percentage of Successful Injections | ABP 938 | Aflibercept |
|---|---|---|
| Percentage of IVT Injections Successfully Administered | 100 (89.1 to 100.0) | 100 (79.4 to 100.0) |
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
| Participants | ABP 938 | Aflibercept |
|---|---|---|
| Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye | 3 | 0 |
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
| Participants | ABP 938 | Aflibercept |
|---|---|---|
| Number of Participants With Serious Ocular TEAEs in Study Eye | 0 | 0 |
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
| Participants | ABP 938 | Aflibercept |
|---|---|---|
| Number of Participants With Non-ocular Serious TEAEs | 0 | 0 |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABP 938 | 0/32 (0%) | 0/32 (0%) | 2/32 (6.3%) |
| Aflibercept | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| Event | ABP 938 | Aflibercept |
|---|---|---|
| Vitreous detachmentEye disorders | 2/32 | 0/16 |
| DiarrhoeaGastrointestinal disorders | 0/32 | 1/16 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/32 | 1/16 |
Full Analysis Set (FAS): All randomized participants.
| Age, Continuous(Years) | ABP 938 | Aflibercept | Total |
|---|---|---|---|
| Mean | 71.0 ± 11.40 | 66.3 ± 15.64 | 69.5 ± 12.97 |
| Sex: Female, Male(Participants) | ABP 938 | Aflibercept | Total |
|---|---|---|---|
| Female | 14 | 2 | 16 |
| Male | 19 | 14 | 33 |
| Ethnicity (NIH/OMB)(Participants) | ABP 938 | Aflibercept | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 4 | 13 |
| Not Hispanic or Latino | 23 | 12 | 35 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | ABP 938 | Aflibercept | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 28 | 14 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
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