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

NCT05989126 | Completed Phase 3 FDA Drug

• 1 other identifier: VGFTe-HD-OD-22105
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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)

Keywords

Neovascular "wet" age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

8 mg Dose

EXPERIMENTAL

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

Interventions

aflibercept 8 mg PFS DRUG

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

Also known as: EYLEA ® HD, BAY86-5321

8 mg Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77385, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: April 15, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (2)