Trial Outcomes & Findings for Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS) (NCT NCT05989126)
NCT ID: NCT05989126
Last Updated: 2026-05-28
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
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
At Day 1
Results posted on
2026-05-28
Participant Flow
Participant milestones
| Measure |
Aflibercept 8 mg PFS
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Baseline characteristics by cohort
| Measure |
Aflibercept 8 mg PFS
n=35 Participants
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 14.27 • n=51 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: At Day 1Participants 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 |
Aflibercept 8 mg PFS
n=35 Participants
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS
|
35 injections
|
SECONDARY outcome
Timeframe: Through Day 29Outcome measures
| Measure |
Aflibercept 8 mg PFS
n=35 Participants
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye
|
2 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Outcome measures
| Measure |
Aflibercept 8 mg PFS
n=35 Participants
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Number of Participants With at Least One Ocular Serious TEAE in the Study Eye
|
0 Participants
|
Adverse Events
Aflibercept 8 mg PFS
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept 8 mg PFS
n=35 participants at risk
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.9%
1/35 • Number of events 1 • From date of informed consent to end of study (up to approximately 43 days)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
1/35 • Number of events 1 • From date of informed consent to end of study (up to approximately 43 days)
|
Other adverse events
| Measure |
Aflibercept 8 mg PFS
n=35 participants at risk
Only 1 eye was selected as the study eye by the investigator. Participants received a single dose utilizing the pre-filled syringe (PFS).
|
|---|---|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Number of events 2 • From date of informed consent to end of study (up to approximately 43 days)
|
Additional Information
Clinical Trials Administrator
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