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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2023-03-24

Brief Summary

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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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Detailed Description

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Conditions

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Chorioretinal Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ABP 938

Intervention Type DRUG

IVT injection

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.

Group Type EXPERIMENTAL

Aflibercept

Intervention Type DRUG

IVT injection

Interventions

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ABP 938

IVT injection

Intervention Type DRUG

Aflibercept

IVT injection

Intervention Type DRUG

Other Intervention Names

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PAVBLU™ Eylea®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No