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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Aflibercept Injection (IAI) | Experimental | Cohort 1 - Initial patients Cohort 2 - Additional patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept Injection (IAI) | Drug | IAI prepared and administered with a pre-filled syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Day 29 |
| Incidence of Ocular Serious TEAEs of Study Eye Through Day 29 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion/ exclusion apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Houston | Texas | 77030 | United States | ||
| Regeneron Study Site |
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A total of 65 participants were enrolled in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1. |
| FG001 | Cohort 2: IAI 2 mg | Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1. |
| BG001 | Cohort 2: IAI 2 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety analysis set (SAF) included all enrolled participants who received study drug. | Posted | Number | Injections | At Day 1 |
|
Up to Day 29
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg | Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage Study Eye | Eye disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals, Inc | 844-734-6643 | clinicaltrials@regeneron.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2020 | Aug 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2019 | Aug 18, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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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. |
| Baseline through Day 29 |
| The Woodlands |
| Texas |
| 77384 |
| United States |
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Number | Participants |
|
Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.
|
|
| Secondary | 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. | SAF included all enrolled participants who received study drug. | Posted | Number | Events | Baseline through Day 29 | Eyes | Eyes |
|
|
|
| Secondary | 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. | SAF included all enrolled participants who received study drug. | Posted | Number | Events | Baseline through Day 29 | Eyes | Eyes |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 6 |
| 35 |
| EG001 | Cohort 2: IAI 2 mg | Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1. | 0 | 30 | 0 | 30 | 1 | 30 |
| Eye irritation Study Eye | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Dry eye |
|
| Eye pain |
|
| Lenticular opacities |
|
| Corneal abrasion |
|