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

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

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.

Study Overview

• Status: Completed
• Conditions: Chorioretinal Vascular Disease
• Intervention / Treatment: Drug: Aflibercept; Drug: ABP 938

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Retina Consultants of Texas - Austin Retina
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas - Bellaire Retina Center
    • San Antonio, Texas, United States, 78240-1657
      • Retinal Consultants of Texas - San Antonio Retina Center
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas - The Woodlands Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP 938; Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.	Drug: ABP 938; IVT injection; Other Names: PAVBLU™
Experimental: Aflibercept; Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.	Drug: Aflibercept; IVT injection; Other Names: Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of IVT Injections Successfully Administered	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.	Day of IVT injection (study day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye	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	Up to 28 days
Number of Participants With Serious Ocular TEAEs in Study Eye	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	Up to 28 days
Number of Participants With Non-ocular Serious TEAEs	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	Up to 28 days

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: aflibercept; CVD; Chorioretinal vascular disease; ABP 938; EYLEA®
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 20210034; 2019-002503-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No