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

Diabetic Macular Edema (DME) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05989126
• Other study ID #: VGFTe-HD-OD-22105
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 15, 2024
• Est. completion date: May 29, 2024

Study information

• Verified date: May 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: May 29, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Retina Consultants of Texas	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of ocular adverse events (AEs) in the study eye		Through Day 29
Secondary	Incidence of ocular severe adverse events (SAEs) in the study eye		Through Day 29