Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
- Conditions
- Chorioretinal Vascular Disease
- Interventions
- Drug: Intravitreal Aflibercept Injection (IAI)
- Registration Number
- NCT03767738
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravitreal Aflibercept Injection (IAI) Intravitreal Aflibercept Injection (IAI) Cohort 1 - Initial patients Cohort 2 - Additional patients
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Regeneron Study Site
🇺🇸The Woodlands, Texas, United States