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

Phase 3

Completed

• Conditions: Diabetic Macular Edema (DME); Neovascular Age-Related Macular Degeneration (nAMD)
• Interventions: Drug: aflibercept 8 mg PFS

• Registration Number: NCT05989126
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2024-04-15
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Key

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

NOTE: Other protocol Defined Inclusion/Exclusion Criteria Apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
8 mg Dose	aflibercept 8 mg PFS	Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.

Primary Outcome Measures

Name	Time	Method
Number of 8 mg aflibercept injections successfully administered utilizing the 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 adverse events (AEs) in the study eye	Through Day 29
Incidence of ocular severe adverse events (SAEs) in the study eye	Through Day 29

Trial Locations

Locations (1)

Retina Consultants of Texas; 🇺🇸 The Woodlands, Texas, United States