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Study Complete
Sponsor ID
20210034

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

Sponsor ID
20210034
Clinicaltrials.gov ID
NCT05704725
EUCTIS ID
N/A
EudraCT ID
2019-002503-17
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
49
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of Successful IVT Injections Utilizing ABP 938

Timeframe: Baseline up to End of Study (approximately 35 days)

Number of Successful IVT Injections Utilizing aflibercept

Timeframe: Baseline up to End of Study (approximately 35 days)

Secondary Outcome Measures

Number of Ocular Adverse Events (AEs)

Timeframe: Up to 35 Days

Number of Serious Adverse Events (SAEs) in the Study Eye

Timeframe: Up to 35 Days

Number of Non-ocular SAEs

Timeframe: Up to 35 Days

Locations

Location
Status
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Location
Retina Consultants of Texas - The Woodlands Retina Center
The Woodlands, Texas, United States, 77384
Status
Recruiting
Location
Retinal Consultants of Texas - San Antonio Retina Center
San Antonio, Texas, United States, 78240-1657
Status
Recruiting
Location
Retina Consultants of Texas - Austin Retina
Austin, Texas, United States, 78705
Status
Recruiting
Location
Retina Consultants of Texas - Bellaire Retina Center
Bellaire, Texas, United States, 77401
Status
Recruiting
Study Info
Age
18 - 99 Years
Condition
  • Chorioretinal Vascular Disease
    • Sex
    All
    Trial Dates
    Jan 2023 - Feb 2023
    Inclusion and Exclusion 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.