Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)

Study Overview
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Brief Summary
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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.

Official Title
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A Study in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration to Evaluate a High Dose Aflibercept (8 mg) Prefilled Syringe

Conditions
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Diabetic Macular Edema (DME), Neovascular Age-Related Macular Degeneration (nAMD)

Intervention / Treatment
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* Drug: aflibercept 8 mg PFS


Participation Criteria
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Eligibility Criteria
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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

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: 8 mg Dose<br>Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS. | Drug: aflibercept 8 mg PFS<br>* Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection<br>* Other names: BAY86-5321;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of 8 mg aflibercept injections successfully administered utilizing the 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 adverse events (AEs) in the study eye |  | Through Day 29 | 
| Incidence of ocular severe adverse events (SAEs) in the study eye |  | Through Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular wet age-related macular degeneration