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

Primary Purpose

Chorioretinal Vascular Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABP 938
Aflibercept
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioretinal Vascular Disease focused on measuring Chorioretinal vascular disease, CVD, ABP 938, Eylea®, aflibercept

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Consultants of Texas - Austin Retina
  • Retina Consultants of Texas - Bellaire Retina Center
  • Retinal Consultants of Texas - San Antonio Retina Center
  • Retina Consultants of Texas - The Woodlands Retina Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ABP 938

Aflibercept

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of Successful IVT Injections Utilizing ABP 938
Number of Successful IVT Injections Utilizing aflibercept

Secondary Outcome Measures

Number of Ocular Adverse Events (AEs)
Number of Serious Adverse Events (SAEs) in the Study Eye
Number of Non-ocular SAEs

Full Information

First Posted
January 20, 2023
Last Updated
September 22, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05704725
Brief Title
A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
Official Title
An Open Label, Two-Arm Study in Subjects With Chorioretinal Vascular Disease to Evaluate ABP 938 and Aflibercept (Eylea®) in a Prefilled Syringe
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioretinal Vascular Disease
Keywords
Chorioretinal vascular disease, CVD, ABP 938, Eylea®, aflibercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABP 938
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABP 938
Intervention Description
IVT injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea®
Intervention Description
IVT injection
Primary Outcome Measure Information:
Title
Proportion of Successful IVT Injections Utilizing ABP 938
Time Frame
Baseline up to End of Study (approximately 35 days)
Title
Number of Successful IVT Injections Utilizing aflibercept
Time Frame
Baseline up to End of Study (approximately 35 days)
Secondary Outcome Measure Information:
Title
Number of Ocular Adverse Events (AEs)
Time Frame
Up to 35 Days
Title
Number of Serious Adverse Events (SAEs) in the Study Eye
Time Frame
Up to 35 Days
Title
Number of Non-ocular SAEs
Time Frame
Up to 35 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Retina Consultants of Texas - Austin Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Texas - Bellaire Retina Center
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Retinal Consultants of Texas - San Antonio Retina Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1657
Country
United States
Facility Name
Retina Consultants of Texas - The Woodlands Retina Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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