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Faricimab PFS Configuration · 1 trial · 2 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| Faricimab PFS Configuration | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Faricimab PFS Configuration | COMBINATION_PRODUCT | Participants will receive a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation delivered via prefilled syringe (PFS) with a co-packaged injection filter needle. |
Inclusion Criteria: * Willing and able to comply with clinic visits and study-related procedures * For female patients of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined in the protoc...
Faricimab PFS Configuration is an investigational small molecule being studied for neovascular age-related macular degeneration, a condition that causes abnormal blood vessel growth in the eye. It is also being evaluated for diabetic macular edema. The drug is in Phase 3 clinical development by Roche Holding AG.
Faricimab PFS Configuration is developed by Roche Holding AG, a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety of this drug in patients with neovascular age-related macular degeneration and diabetic macular edema.
Faricimab PFS Configuration is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety in patients with neovascular age-related macular degeneration and diabetic macular edema.
Faricimab PFS Configuration has one completed Phase 3 trial, NCT05569148, which evaluated the safety of the faricimab prefilled syringe in patients with neovascular age-related macular degeneration or diabetic macular edema. The trial enrolled 35 participants in the United States and was not randomized or double-blinded.
Faricimab PFS Configuration refers to a prefilled syringe configuration of faricimab, a drug being studied for neovascular age-related macular degeneration and diabetic macular edema. The clinical trial NCT05569148 specifically evaluates the safety of the faricimab prefilled syringe in these conditions.