A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)

Last updated: February 12, 2025
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Treatment

Aflibercept

ABP 938

Clinical Study ID

NCT05704725
20210034
2019-002503-17
  • Ages 18-99
  • All Genders

Study Summary

The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Must sign an IRB approved informed consent form before any study-specific procedures are initiated.

  • Men or women ≥18 years old.

  • Treatment-naïve or previously treated neovascular age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, or diabetic retinopathy in the study eye.

Exclusion Criteria

  • Active intraocular or periocular infection or active intraocular inflammation in either eye.

  • Uncontrolled intraocular pressure greater than (>) 25 mmHg in the study eye.

  • Deemed legally blind in one or both eyes.

  • History of or any current indication of excessive bleeding or recurrent hemorrhages, including any prior excessive intraocular bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.

  • Current systemic infectious disease or on a therapy for active infectious disease.

  • History of any medical, ocular or non-ocular conditions that, in the opinion of the investigator, may interfere with the injection procedure or pose a safety concern.

  • History of stroke or transient ischemic attacks or myocardial infarction within the last 6 months.

  • Treatment with anti-VEGF IVT injection in the study eye within 28 days.

  • Any use of intraocular corticosteroids in the study eye within 3 months.

  • Receipt of any systemic anti-VEGF within the last 6 months.

  • Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye within the past 3 months.

  • For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after IP administration.

  • Sexually active participants and their partners who are of childbearing potential who refuse to use adequate contraception while on-study and for 3 months after IP administration. Male participants must agree not to donate sperm during study and for 3 months following dose of IP.

  • Allergy or hypersensitivity to the IP, to any of the excipients of ABP 938 or aflibercept, or to other study-related procedures/medications.

  • Previously enrolled in this study.

  • Participation in any interventional clinical study within 3 months prior to screening.

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: Aflibercept
Phase: 3
Study Start date:
January 23, 2023
Estimated Completion Date:
March 24, 2023

Connect with a study center

  • Retina Consultants of Texas - Austin Retina

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas - Bellaire Retina Center

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retinal Consultants of Texas - San Antonio Retina Center

    San Antonio, Texas 78240-1657
    United States

    Site Not Available

  • Retina Consultants of Texas - The Woodlands Retina Center

    The Woodlands, Texas 77384
    United States

    Site Not Available

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