Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Study Overview
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Brief Summary
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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.

Official Title
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A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Conditions
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Chorioretinal Vascular Disease

Intervention / Treatment
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* Drug: Intravitreal Aflibercept Injection (IAI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal Aflibercept Injection (IAI)<br>Cohort 1 - Initial patients Cohort 2 - Additional patients | Drug: Intravitreal Aflibercept Injection (IAI)<br>* IAI prepared and administered with a pre-filled syringe (PFS)<br>* Other names: EYLEA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) | 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. | At Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye 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. | Baseline through Day 29 | 
| Incidence of Ocular Serious TEAEs of Study Eye 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. | Baseline through Day 29 |