Chorioretinal Vascular DiseasePhase 3NCT05704725
A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)
A Phase 3 study testing ABP 938 and Aflibercept in people with Chorioretinal Vascular Disease, run by Amgen at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chorioretinal Vascular Disease
- What is being tested?
- ABP 938 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jan 2023to 24 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Retina Consultants of Texas - Austin Retina
Austin, Texas, 78705
Retina Consultants of Texas - Bellaire Retina Center
Bellaire, Texas, 77401
Retinal Consultants of Texas - San Antonio Retina Center
San Antonio, Texas, 78240-1657
Retina Consultants of Texas - The Woodlands Retina Center
The Woodlands, Texas, 77384
About this study
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
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.
- Conditions
- Chorioretinal Vascular Disease
- Being tested
- ABP 938, Aflibercept
- Keywords
- Chorioretinal vascular disease, CVD, ABP 938, EYLEA®, aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 938Drug
Also called PAVBLU™
IVT injection
AfliberceptDrug
Also called Eylea®
IVT injection
| Study group | Role | What they receive |
|---|---|---|
| ABP 938 | Experimental | 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. Receives: Drug: ABP 938 |
| Aflibercept | Experimental | 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. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of IVT Injections Successfully Administered
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
Measured: Day of IVT injection (study day 1)
Secondary outcomes (3)
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. Events that met the AE definition are as follows:
- Any abnormal or worsening ocular safety result that is considered clinically significant in the medical and scientific judgment of the investigator.
- Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
- New conditions detected or diagnosed after study treatment administration even though it may have been present before the start of the study.
- Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a concomitant medication.
AEs were classified by system organ class (SOC) according to the Medical Dictionary for Regulatory Activities (medDRA) and graded by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: Up to 28 days
Number of Participants With Serious Ocular TEAEs in Study Eye
A serious AE is any event that met at least 1 of the following serious criteria:
- Fatal.
- Life-threatening (places the participant at immediate risk of death).
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in persistent or significant disability/incapacity.
- Congenital anomaly/birth defect.
- Other medically important serious event.
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0
Measured: Up to 28 days
Number of Participants With Non-ocular Serious TEAEs
A serious AE is any event that met at least 1 of the following serious criteria:
- Fatal.
- Life-threatening (places the participant at immediate risk of death).
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in persistent or significant disability/incapacity.
- Congenital anomaly/birth defect.
- Other medically important serious event.
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start23 Jan 2023
- Primary completion17 Feb 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chorioretinal Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704725
- Sponsor's protocol ID
- 20210034
- Other IDs
- 2019-002503-17, 2019
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2023
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704725
- Acronym / sponsor ID
- 20210034
- Conditions
- Chorioretinal Vascular Disease
- Keywords
- Chorioretinal vascular disease, CVD, ABP 938, EYLEA®, aflibercept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP 938 | Experimental | Drug: ABP 938Participants 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. |
| Aflibercept | Experimental | Drug: AfliberceptParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP 938Also: PAVBLU™IVT injection | Drug | ABP 938 |
| AfliberceptAlso: Eylea®IVT injection | Drug | Aflibercept |
Primary outcome
Percentage of IVT Injections Successfully Administered
Time frame: Day of IVT injection (study day 1)
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
3 secondary outcomes
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye
Time frame: Up to 28 days
Number of Participants With Serious Ocular TEAEs in Study Eye
Time frame: Up to 28 days
Number of Participants With Non-ocular Serious TEAEs
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Chorioretinal Vascular Disease
RecruitingObservational study
Analysis of Biomarkers From Patients With Chorioretinal Diseases
Diabetic Retinopathy, Macular Degeneration
RecruitingObservational study
OCT in Rare Chorioretinal Diseases
Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABP 938 and Aflibercept in people with Chorioretinal Vascular Disease, run by Amgen at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of IVT Injections Successfully Administered (time frame: Day of IVT injection (study day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.