Clincosm LogoSign in Get a demo

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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05989126
Collaborator
(none)
35
Enrollment
1
Arm
3.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Regeneron Pharmaceuticals developed a single-dose glass 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: aflibercept 8 mg PFS
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 13, 2023
Anticipated Primary Completion Date :
Jan 17, 2024
Anticipated Study Completion Date :
Jan 17, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: aflibercept 8 mg PFS
Sterile aqueous solution in a single-dose glass PFS administered by intravitreal (IVT) injection
Other Names:
  • EYLEA ®
  • BAY86-5321

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Incidence of ocular adverse events (AEs) in the study eye [Through Day 29]

    2. Incidence of ocular severe adverse events (SAEs) in the study eye [Through Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05989126
    Other Study ID Numbers:
    • VGFTe-HD-OD-22105
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Neovascular "wet" age-related macular degeneration
    Additional relevant MeSH terms:
    Macular Degeneration
    Macular Edema
    Wet Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Aug 14, 2023