Phase 3
N=35
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Diabetic Macular Edema (DME) · Neovascular Age-Related Macular Degeneration (nAMD)
Bottom Line
View on ClinicalTrials.gov: NCT05989126 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
May 2026
Primary outcome: Primary: Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS — 35 injections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- aflibercept 8 mg PFS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS |
35 | — |
| SECONDARY Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye |
2 | — |
| SECONDARY Number of Participants With at Least One Ocular Serious TEAE in the Study Eye |
— | — |
Summary
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial.
This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).
The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.
Eligibility Criteria
Key Inclusion Criteria
- Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye
- Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept
Key Exclusion Criteria
- Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye
- Treatment with any IVT injection in the study eye within the 25 days prior to day 1
- Intraocular pressure (IOP) >25 mm Hg in the study eye at screening
- Any intraocular surgery in the study eye at any time during the past 3 months
- Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye
NOTE: Other protocol Defined Inclusion/Exclusion Criteria Apply
Data sourced from ClinicalTrials.gov (NCT05989126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.