Clinical trial NCT05989126: Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema (DME)
Neovascular Age-Related Macular Degeneration (nAMD)
Keywords: Neovascular "wet" age-related macular degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of 8 mg aflibercept injections successfully administered utilizing the PFS
timeFrame: At Day 1
Secondary outcomes:
measure: Incidence of ocular adverse events (AEs) in the study eye
timeFrame: Through Day 29
measure: Incidence of ocular severe adverse events (SAEs) in the study eye
timeFrame: Through Day 29
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: