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

Part of paid clinical trials in Bellaire, Texas.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05989126
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept 8 mg PFS — DRUG
    Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection

Study Details

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.

Key Dates

Start date
Apr 15, 2024
Status verified
Apr 2026
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS [ Time Frame: At Day 1 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Retina Consultants of TexasBellaireTexas77401-
Retina Consultants of TexasThe WoodlandsTexas77385-

Find similar trials in Bellaire, TX

By research site
Retina Consultants of Texas· Bellaire, TXRetina Consultants of Texas· The Woodlands, TX

Related Studies