Phase 4
Completed N=65
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Chorioretinal Vascular Disease
Source: ClinicalTrials.gov NCT03767738 ↗
Enrolled (actual)
65
Serious AEs
1.5%
Results posted
Sep 2021
Primary outcomePrimary: Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) — 35; 29 Injections
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) |
35; 29 | — |
| SECONDARY Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29 |
3; 1; 3; 0; 0; 1 | — |
| SECONDARY Incidence of Ocular Serious TEAEs of Study Eye Through Day 29 |
0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03767738). 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. Informational only — not medical advice.