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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002503-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP 938 | Drug | IVT injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of IVT injection (study day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Texas - Austin Retina | Austin | Texas | 78705 | United States | ||
| Retina Consultants of Texas - Bellaire Retina Center |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Participants were randomized in a ratio of 2:1 to receive either a single intravitreal (IVT) injection of ABP 938 in a pre-filled syringe (PFS) or a single injection of aflibercept in a PFS.
This study was conducted at 4 centers in the United States between 23 January 2023 and 24 March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABP 938 | Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS. |
| FG001 | Aflibercept | Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | ABP 938 | Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS. |
| BG001 | Aflibercept | Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS. |
| 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 | 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. | FAS (only participants with available data are included.) | Posted | Number | 95% Confidence Interval | Percentage of Successful Injections | Day of IVT injection (study day 1) |
|
28 days
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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 | ABP 938 | Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous detachment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.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 | Oct 19, 2022 | Jan 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2022 | Jan 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Aflibercept |
| Drug |
IVT injection |
|
|
| 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:
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0 | 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:
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0 | Up to 28 days |
| Bellaire |
| Texas |
| 77401 |
| United States |
| Retinal Consultants of Texas - San Antonio Retina Center | San Antonio | Texas | 78240-1657 | United States |
| Retina Consultants of Texas - The Woodlands Retina Center | The Woodlands | Texas | 77384 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
|
|
| Secondary | 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:
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 | Safety Analysis Set (SAS): all randomized participants who received investigational product. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| Secondary | 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:
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0 | SAS | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| Secondary | Number of Participants With Non-ocular Serious TEAEs | A serious AE is any event that met at least 1 of the following serious criteria:
AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0 | SAS | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| EG001 | Aflibercept | Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS. | 0 | 16 | 0 | 16 | 2 | 16 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.