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

Study Overview
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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.

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

Conditions
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Chorioretinal Vascular Disease

Intervention / Treatment
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* Drug: ABP 938
* Drug: Aflibercept


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP 938<br>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<br>* IVT injection<br>|
| Experimental: Aflibercept<br>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<br>* IVT injection<br>* Other names: Eylea®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVD, Chorioretinal vascular disease, ABP 938, Eylea®, aflibercept