Chorioretinal Vascular DiseasePhase 4NCT03767738
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
A Phase 4 study testing Intravitreal Aflibercept Injection (IAI) in people with Chorioretinal Vascular Disease, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection. The secondary objective of the study is to assess ocular safety in the study eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chorioretinal Vascular Disease
- What is being tested?
- Intravitreal Aflibercept Injection (IAI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2018to 19 Aug 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye
Who cannot join
- Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
- History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
- Any intraocular surgery in the study eye at any time during the past 3 months
- Current systemic infectious disease or a therapy for active infectious disease
- Pregnant or breastfeeding women
- Note: Other inclusion/ exclusion apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
The Woodlands, Texas, 77384
About this study
Official title: A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.
The secondary objective of the study is to assess ocular safety in the study eye.
- Conditions
- Chorioretinal Vascular Disease
- Being tested
- Intravitreal Aflibercept Injection (IAI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept Injection (IAI)Drug
Also called Aflibercept, EYLEA®
IAI prepared and administered with a pre-filled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept Injection (IAI) | Experimental | Cohort 1 - Initial patients Cohort 2 - Additional patients Receives: Drug: Intravitreal Aflibercept Injection (IAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
Measured: At Day 1
Secondary outcomes (2)
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Measured: Baseline through Day 29
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Measured: Baseline through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start19 Dec 2018
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
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 Regeneron PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767738
- Sponsor's protocol ID
- VGFTe-OD-1881
- Status last verified
- Aug 2021
- First submitted
- 5 Dec 2018
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
- ClinicalTrials.gov ID
- NCT03767738
- Acronym / sponsor ID
- VGFTe-OD-1881
- Conditions
- Chorioretinal Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 16 Sep 2021
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 the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.
The secondary objective of the study is to assess ocular safety in the study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept Injection (IAI) | Experimental | Drug: Intravitreal Aflibercept Injection (IAI)Cohort 1 - Initial patients Cohort 2 - Additional patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye
Key exclusion criteria (7 listed)
- Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
- History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
- Any intraocular surgery in the study eye at any time during the past 3 months
- Current systemic infectious disease or 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 |
|---|---|---|
| Intravitreal Aflibercept Injection (IAI)Also: Aflibercept, EYLEA®IAI prepared and administered with a pre-filled syringe (PFS) | Drug | Intravitreal Aflibercept Injection (IAI) |
Primary outcome
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Time frame: At Day 1
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
2 secondary outcomes
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Time frame: Baseline through Day 29
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
Time frame: Baseline through Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal Aflibercept Injection (IAI) in people with Chorioretinal Vascular Disease, run by Regeneron Pharmaceuticals at 2 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 1 inclusion and 7 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Sep 2021). 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?
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS) (time frame: At 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 16 Sep 2021.