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This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.
The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTH258 | Experimental | brolucizumab 6 mg in a prefilled syringe |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTH258 | Drug | 6 mg in prefilled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | The safety is defined as the incidence of ocular and non-ocular adverse events | Up to Day 31 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Altamonte Springs | Florida | 32701 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com
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Thirty-five subjects were enrolled and 34 received one IVT injection of brolucizumab 6 mg PFS. One subject withdrew consent before receiving treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | RTH258 | Brolucizumab 6 mg in a prefilled syringe |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 11, 2019 | Jun 23, 2020 |
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study with a single arm: brolucizumab 6 mg PFS
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open label study
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| Pensacola |
| Florida |
| 32503 |
| United States |
| Novartis Investigative Site | Richmond | Virginia | 23235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RTH258 | Brolucizumab 6 mg in a prefilled syringe |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | The safety is defined as the incidence of ocular and non-ocular adverse events | Full Analysis Set | Posted | Number | Participants | Up to Day 31 |
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Adverse events were collected from first dose of study treatment until end of study treatment plus 30 post treatment, up to maximum duration of approximately two months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Normal reporting of treatment emergent AEs which are not SAEs are normally reported with an incidence greater than or equal to 5%.
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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 | RTH258 | Brolucizumab 6 mg in a prefilled syringe | 0 | 34 | 0 | 34 | 0 | 34 |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2019 | Jun 23, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000622091 | brolucizumab |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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