Clinical trial NCT05704725: A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chorioretinal Vascular Disease
Keywords: Chorioretinal vascular disease
CVD
ABP 938
EYLEA®
aflibercept
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of IVT Injections Successfully Administered
timeFrame: Day of IVT injection (study day 1)
Secondary outcomes:
measure: Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye
timeFrame: Up to 28 days
measure: Number of Participants With Serious Ocular TEAEs in Study Eye
timeFrame: Up to 28 days
measure: Number of Participants With Non-ocular Serious TEAEs
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Retina Consultants of Texas - Austin Retina
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas - Bellaire Retina Center
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas - San Antonio Retina Center
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas - The Woodlands Retina Center
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: