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

NCT ID: NCT05989126

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-05-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

8 mg Dose

Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.

Group Type: EXPERIMENTAL

aflibercept 8 mg PFS

Intervention Type: DRUG

Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection

Interventions

aflibercept 8 mg PFS

Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection

Intervention Type: DRUG

Other Intervention Names

EYLEA ® HD; BAY86-5321

Eligibility Criteria

Inclusion Criteria

1. Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye

2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept

Exclusion Criteria

1. 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

2. Treatment with any IVT injection in the study eye within the 25 days prior to day 1

3. Intraocular pressure (IOP) >25 mm Hg in the study eye at screening

4. Any intraocular surgery in the study eye at any time during the past 3 months

5. Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Retina Consultants of Texas

Bellaire, Texas, United States

Retina Consultants of Texas

The Woodlands, Texas, United States

Countries

United States

Other Identifiers

VGFTe-HD-OD-22105

Identifier Type: -

Identifier Source: org_study_id