Chorioretinal Vascular Disease
Conditions
Brief summary
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection. The secondary objective of the study is to assess ocular safety in the study eye.
Interventions
IAI prepared and administered with a pre-filled syringe (PFS)
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye Key
Exclusion criteria
* Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye * Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye * History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye * Any intraocular surgery in the study eye at any time during the past 3 months * Current systemic infectious disease or a therapy for active infectious disease * Pregnant or breastfeeding women Note: Other inclusion/ exclusion apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) | At Day 1 | Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Baseline through Day 29 | A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication. |
| Incidence of Ocular Serious TEAEs of Study Eye Through Day 29 | Baseline through Day 29 | A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication. |
Countries
United States
Participant flow
Recruitment details
A total of 65 participants were enrolled in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1. | 35 |
| Cohort 2: IAI 2 mg Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1. | 30 |
| Total | 65 |
Baseline characteristics
| Characteristic | Total | Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Cohort 2: IAI 2 mg |
|---|---|---|---|
| Age, Continuous | 68.8 Years STANDARD_DEVIATION 12.23 | 72.2 Years STANDARD_DEVIATION 10.04 | 64.7 Years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 32 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 57 Participants | 32 Participants | 25 Participants |
| Sex: Female, Male Female | 34 Participants | 20 Participants | 14 Participants |
| Sex: Female, Male Male | 31 Participants | 15 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 30 |
| other Total, other adverse events | 6 / 35 | 1 / 30 |
| serious Total, serious adverse events | 1 / 35 | 0 / 30 |
Outcome results
Primary
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
Time frame: At Day 1
Population: Safety analysis set (SAF) included all enrolled participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) | 35 Injections |
| Cohort 2: IAI 2 mg | Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) | 29 Injections |
Secondary
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Time frame: Baseline through Day 29
Population: SAF included all enrolled participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Serious TEAEs of Study Eye Through Day 29 | 0 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Serious TEAEs of Study Eye Through Day 29 | 0 Events |
Secondary
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Time frame: Baseline through Day 29
Population: SAF included all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Conjunctival haemorrhage | 3 Events |
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Eye irritation | 3 Events |
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Dry eye | 0 Events |
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Eye pain | 0 Events |
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Lenticular opacities | 0 Events |
| Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Corneal abrasion | 1 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Lenticular opacities | 1 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Conjunctival haemorrhage | 1 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Eye pain | 1 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Eye irritation | 0 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Corneal abrasion | 0 Events |
| Cohort 2: IAI 2 mg | Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 | Dry eye | 1 Events |