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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05989126
Other study ID # VGFTe-HD-OD-22105
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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