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Completed

NCT Number: NCT05704725

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

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.

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Key information

Conditions

Chorioretinal Vascular Disease

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina Consultants of Texas - Austin Retina, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABP 938

Drug

IVT injection

Other names: PAVBLU™

aflibercept

Drug

IVT injection

Other names: Eylea®

Primary outcomes

  1. Percentage of IVT Injections Successfully Administered

    Time frame: Day of IVT injection (study day 1)

    A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.

Secondary outcomes

  1. Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye

    Time frame: Up to 28 days

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. Events that met the AE definition are as follows:

    • Any abnormal or worsening ocular safety result that is considered clinically significant in the medical and scientific judgment of the investigator.
    • Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
    • New conditions detected or diagnosed after study treatment administration even though it may have been present before the start of the study.
    • Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a concomitant medication.

    AEs were classified by system organ class (SOC) according to the Medical Dictionary for Regulatory Activities (medDRA) and graded by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

  2. Number of Participants With Serious Ocular TEAEs in Study Eye

    Time frame: Up to 28 days

    A serious AE is any event that met at least 1 of the following serious criteria:

    • Fatal.
    • Life-threatening (places the participant at immediate risk of death).
    • Requires inpatient hospitalization or prolongation of existing hospitalization.
    • Results in persistent or significant disability/incapacity.
    • Congenital anomaly/birth defect.
    • Other medically important serious event.

    AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0

  3. Number of Participants With Non-ocular Serious TEAEs

    Time frame: Up to 28 days

    A serious AE is any event that met at least 1 of the following serious criteria:

    • Fatal.
    • Life-threatening (places the participant at immediate risk of death).
    • Requires inpatient hospitalization or prolongation of existing hospitalization.
    • Results in persistent or significant disability/incapacity.
    • Congenital anomaly/birth defect.
    • Other medically important serious event.

    AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open Label, Two-Arm Study in Subjects With Chorioretinal Vascular Disease to Evaluate ABP 938 and Aflibercept (Eylea®) in a Prefilled Syringe

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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