Phase 3
N=49
A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
Chorioretinal Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT05704725 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Percentage of IVT Injections Successfully Administered — 100; 100 Percentage of Successful Injections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABP 938 (Drug); Aflibercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of IVT Injections Successfully Administered |
100; 100 | — |
| SECONDARY Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye |
3; 0 | — |
| SECONDARY Number of Participants With Serious Ocular TEAEs in Study Eye |
0; 0 | — |
| SECONDARY Number of Participants With Non-ocular Serious TEAEs |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05704725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.