Trial Outcomes & Findings for A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe (NCT NCT05569148)
NCT ID: NCT05569148
Last Updated: 2023-10-10
Results Overview
Thirteen healthcare providers (HCP; seven retina specialists and six assistants) across three sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A successful task completion for each critical task was defined as normal use without use error, and the percentages of successful completions are calculated out of the total 35 PFS IVT injections administered.
COMPLETED
PHASE3
35 participants
Day 1
2023-10-10
Participant Flow
Participant milestones
| Measure |
Faricimab PFS Configuration
Healthcare providers (HCP) prepared and administered a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation to each patient via prefilled syringe (PFS) with a co-packaged injection filter needle on Day 1.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
Baseline characteristics by cohort
| Measure |
Faricimab PFS Configuration
n=35 Participants
Healthcare providers (HCP) prepared and administered a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation to each patient via prefilled syringe (PFS) with a co-packaged injection filter needle on Day 1.
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|---|---|
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Age, Continuous
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74.7 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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16 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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Underlying Condition in Study Eye
DME Only
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12 Participants
n=5 Participants
|
|
Underlying Condition in Study Eye
nAMD Only
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22 Participants
n=5 Participants
|
|
Underlying Condition in Study Eye
Both DME and nAMD
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The target population included all 35 enrolled patients. Thirteen HCPs (7 retina specialists and 6 assistants) performed tasks to prepare and administer a single faricimab PFS IVT injection to each of the 35 patients. Certain critical tasks could only be performed by the retina specialists.
Thirteen healthcare providers (HCP; seven retina specialists and six assistants) across three sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A successful task completion for each critical task was defined as normal use without use error, and the percentages of successful completions are calculated out of the total 35 PFS IVT injections administered.
Outcome measures
| Measure |
Faricimab PFS Configuration
n=35 Injection Procedures
Healthcare providers (HCP) prepared and administered a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation to each patient via prefilled syringe (PFS) with a co-packaged injection filter needle on Day 1.
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|---|---|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Open Folding Box
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Remove Leaflet and Tray with Syringe from Folding Box
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Aseptically Attach Supplied Injection Filter Needle Onto Syringe Luer Connector
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Remove Injection Filter Needle Cap
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Hold Syringe Upright
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
If Air Bubbles are Present, Tap to Force Air Bubbles to the Top of the Syringe
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Slowly Push the Plunger to Align the Stopper to the Syringe 0.05 mL Dose Mark
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Insert Injection Filter Needle at the Injection Site
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Inject Slowly Until Stopper Reaches the End of the Syringe Barrel to Deliver the Volume of 0.05 mL
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100 Percentage of injection procedures
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Remove Injection Filter Needle from the Injection Site
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100 Percentage of injection procedures
|
|
Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Dispose of Used Syringe with Uncapped Needle in a Sharps Disposal Container
|
100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Remove Supplied Injection Filter Needle from Folding Box
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Peel Lid off the Tray
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Aseptically Remove Syringe from Tray
|
100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Split Open Pouch
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Aseptically Remove Injection Filter Needle
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100 Percentage of injection procedures
|
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Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
Remove Syringe Tip Cap
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100 Percentage of injection procedures
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PRIMARY outcome
Timeframe: Day 1Population: The target population included all 35 enrolled patients. Thirteen HCPs (7 retina specialists and 6 assistants) performed tasks to prepare and administer a single faricimab PFS IVT injection to each of the 35 patients. Certain critical tasks could only be performed by the retina specialists.
Thirteen healthcare providers (HCP) across 3 sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A use error was defined as user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user. The percentages of use errors are calculated out of the total 35 PFS IVT injections administered.
Outcome measures
| Measure |
Faricimab PFS Configuration
n=35 Injection Procedures
Healthcare providers (HCP) prepared and administered a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation to each patient via prefilled syringe (PFS) with a co-packaged injection filter needle on Day 1.
|
|---|---|
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Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
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0 Percentage of injection procedures
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Adverse Events
Faricimab PFS Configuration
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Faricimab PFS Configuration
n=35 participants at risk
Healthcare providers (HCP) prepared and administered a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation to each patient via prefilled syringe (PFS) with a co-packaged injection filter needle on Day 1.
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|---|---|
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Eye disorders
Eye irritation
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2.9%
1/35 • Number of events 1 • From Day 1 to Day 7
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER