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

Sponsor

Amgen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05704725

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chorioretinal Vascular Disease	Drug: ABP 938 Drug: Aflibercept	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Mar 28, 2023

Anticipated Study Completion Date :

Mar 28, 2023

Arms and Interventions

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
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®

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

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®

Outcome Measures

Primary Outcome Measures

Proportion of Successful IVT Injections Utilizing ABP 938 [Baseline up to End of Study (approximately 35 days)]
Number of Successful IVT Injections Utilizing aflibercept [Baseline up to End of Study (approximately 35 days)]

Secondary Outcome Measures

Number of Ocular Adverse Events (AEs) [Up to 35 Days]
Number of Serious Adverse Events (SAEs) in the Study Eye [Up to 35 Days]
Number of Non-ocular SAEs [Up to 35 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.