Trial Outcomes & Findings for Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe (NCT NCT03767738)
NCT ID: NCT03767738
Last Updated: 2021-09-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
At Day 1
Results posted on
2021-09-16
Participant Flow
A total of 65 participants were enrolled in the United States.
Unit of analysis: Eyes
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35 35
|
30 30
|
|
Overall Study
COMPLETED
|
35 35
|
30 30
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Baseline characteristics by cohort
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 Participants
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 Participants
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.2 Years
STANDARD_DEVIATION 10.04 • n=93 Participants
|
64.7 Years
STANDARD_DEVIATION 13.44 • n=4 Participants
|
68.8 Years
STANDARD_DEVIATION 12.23 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: Safety analysis set (SAF) included all enrolled participants who received study drug.
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.
Outcome measures
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 Participants
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 Participants
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|---|---|---|
|
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
|
35 Injections
|
29 Injections
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: SAF included all enrolled participants who received study drug.
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.
Outcome measures
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 Eyes
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 Eyes
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|---|---|---|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Corneal abrasion
|
1 Events
|
0 Events
|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Conjunctival haemorrhage
|
3 Events
|
1 Events
|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Eye irritation
|
3 Events
|
0 Events
|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Dry eye
|
0 Events
|
1 Events
|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Eye pain
|
0 Events
|
1 Events
|
|
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Lenticular opacities
|
0 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: SAF included all enrolled participants who received study drug.
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.
Outcome measures
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 Eyes
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 Eyes
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|---|---|---|
|
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
|
0 Events
|
0 Events
|
Adverse Events
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: IAI 2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 participants at risk
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 participants at risk
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.9%
1/35 • Number of events 1 • Up to Day 29
|
0.00%
0/30 • Up to Day 29
|
Other adverse events
| Measure |
Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg
n=35 participants at risk
Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.
|
Cohort 2: IAI 2 mg
n=30 participants at risk
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage Study Eye
|
8.6%
3/35 • Number of events 3 • Up to Day 29
|
3.3%
1/30 • Number of events 1 • Up to Day 29
|
|
Eye disorders
Eye irritation Study Eye
|
8.6%
3/35 • Number of events 3 • Up to Day 29
|
0.00%
0/30 • Up to Day 29
|
Additional Information
Clinical Trial Management
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER