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

• Status: Not yet recruiting
• Trial end date: 2023-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Aflibercept

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.