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

NCT05704725 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 202100342019-002503-17
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chorioretinal Vascular Disease

Keywords

Chorioretinal vascular disease; CVD; ABP 938; EYLEA®; aflibercept

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Up to 28 days

• Number of Participants With Serious Ocular TEAEs in Study Eye

  Up to 28 days

• Number of Participants With Non-ocular Serious TEAEs

  Up to 28 days

Study Arms (2)

ABP 938

EXPERIMENTAL

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

Aflibercept

EXPERIMENTAL

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

Interventions

ABP 938 DRUG

IVT injection

Also known as: PAVBLU™

ABP 938

Aflibercept DRUG

IVT injection

Also known as: Eylea®

Aflibercept

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

Retina Consultants of Texas - Austin Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas - Bellaire Retina Center

Bellaire, Texas, 77401, United States

Location

Retinal Consultants of Texas - San Antonio Retina Center

San Antonio, Texas, 78240-1657, United States

Location

Retina Consultants of Texas - The Woodlands Retina Center

The Woodlands, Texas, 77384, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: January 23, 2023
• Primary Completion: February 17, 2023
• Study Completion: March 24, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (4)