Chorioretinal Vascular Disease
Conditions
Keywords
Chorioretinal vascular disease, CVD, ABP 938, EYLEA®, aflibercept
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.
Interventions
DRUGABP 938
IVT injection
DRUGAflibercept
IVT injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Must sign an IRB approved informed consent form before any study-specific procedures are initiated. * Men or women ≥18 years old. * Treatment-naïve or previously treated neovascular age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, or diabetic retinopathy in the study eye.
Exclusion criteria
* Active intraocular or periocular infection or active intraocular inflammation in either eye. * Uncontrolled intraocular pressure greater than (\>) 25 mmHg in the study eye. * Deemed legally blind in one or both eyes. * History of or any current indication of excessive bleeding or recurrent hemorrhages, including any prior excessive intraocular bleeding or hemorrhages after IVT injection or intraocular procedures in either eye. * Current systemic infectious disease or on a therapy for active infectious disease. * History of any medical, ocular or non-ocular conditions that, in the opinion of the investigator, may interfere with the injection procedure or pose a safety concern. * History of stroke or transient ischemic attacks or myocardial infarction within the last 6 months. * Treatment with anti-VEGF IVT injection in the study eye within 28 days. * Any use of intraocular corticosteroids in the study eye within 3 months. * Receipt of any systemic anti-VEGF within the last 6 months. * Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye within the past 3 months. * For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after IP administration. * Sexually active participants and their partners who are of childbearing potential who refuse to use adequate contraception while on-study and for 3 months after IP administration. Male participants must agree not to donate sperm during study and for 3 months following dose of IP. * Allergy or hypersensitivity to the IP, to any of the excipients of ABP 938 or aflibercept, or to other study-related procedures/medications. * Previously enrolled in this study. * Participation in any interventional clinical study within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 5.0 |
| Number 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 5.0 |
| Number 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 |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 4 centers in the United States between 23 January 2023 and 24 March 2023.
Pre-assignment details
Participants were randomized in a ratio of 2:1 to receive either a single intravitreal (IVT) injection of ABP 938 in a pre-filled syringe (PFS) or a single injection of aflibercept in a PFS.
Participants by arm
| Arm | Count |
|---|---|
| ABP 938 Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS. | 33 |
| Aflibercept Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS. | 16 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Aflibercept | Total | ABP 938 |
|---|---|---|---|
| Age, Continuous | 66.3 Years STANDARD_DEVIATION 15.64 | 69.5 Years STANDARD_DEVIATION 12.97 | 71.0 Years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 13 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 35 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 42 Participants | 28 Participants |
| Sex: Female, Male Female | 2 Participants | 16 Participants | 14 Participants |
| Sex: Female, Male Male | 14 Participants | 33 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 16 |
| other Total, other adverse events | 2 / 32 | 2 / 16 |
| serious Total, serious adverse events | 0 / 32 | 0 / 16 |
Outcome results
Primary
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)
Population: FAS (only participants with available data are included.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABP 938 | Percentage of IVT Injections Successfully Administered | 100 Percentage of Successful Injections |
| Aflibercept | Percentage of IVT Injections Successfully Administered | 100 Percentage of Successful Injections |
Secondary
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
Population: SAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABP 938 | Number of Participants With Non-ocular Serious TEAEs | 0 Participants |
| Aflibercept | Number of Participants With Non-ocular Serious TEAEs | 0 Participants |
Secondary
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
Population: Safety Analysis Set (SAS): all randomized participants who received investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABP 938 | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye | 3 Participants |
| Aflibercept | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye | 0 Participants |
Secondary
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
Population: SAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABP 938 | Number of Participants With Serious Ocular TEAEs in Study Eye | 0 Participants |
| Aflibercept | Number of Participants With Serious Ocular TEAEs in Study Eye | 0 Participants |