Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Conditions
Brief summary
This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events occurring during the 7-day study reporting period will be summarized.
Interventions
COMBINATION_PRODUCTFaricimab PFS Configuration
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 protocol * Confirmed diagnosis of neovascular age-related macular degeneration (nAMD; any subtype) or diabetic macular edema (DME) in one or both eyes by the study site investigator (only one eye will be selected as the study eye, as determined by the retina specialist) with onset at any time prior to study start * Study eye is deemed to be indicated for faricimab intravitreal (IVT) treatment at the discretion of the retina specialist * Hstorical optical coherence tomography (OCT) data available for the study eye within 30 days prior to Day 1
Exclusion criteria
* Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final dose of faricimab * Requirement on Day 1 for continuous use of any medications and treatments considered prohibited therapy per the protocol * Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day 1 * Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1 * History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab prefilled syringe injection, study-related procedure preparations, or any of the anesthetic and antimicrobial preparations used by a participant during the study * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of faricimab or renders the patient at high risk for treatment complications in the opinion of the investigator * Uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg while a patient is at rest) * Systemic treatment for suspected or active systemic infection on Day 1 * Legally blind in the study eye on Day 1 (legal blindness: Best-corrected visual acuity \[BCVA\] of 20/200 or less) * History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction (any grading from trace and greater is excluded), including non-infectious uveitis or infectious uveitis, or sterile inflammatory reaction after previous IVT injections with any agent in either eye * Suspected or active ocular or periocular infection in either eye on Day 1 * History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular or subconjunctival bleeding or hemorrhages after IVT injection or intraocular procedures in either eye * Uncontrolled glaucoma in the study eye * Treatment with any IVT injection in the study eye within the 27 days prior to Day 1 * Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the 3 months prior to Day 1 * Treatment with panretinal photocoagulation, laser retinopexy or macular (focal, grid, or micropulse) laser in the study eye within one month prior to Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration | Day 1 | 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. |
| Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration | Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Faricimab PFS Configuration |
|---|---|
| Age, Continuous | 74.7 Years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 19 Participants |
| Underlying Condition in Study Eye Both DME and nAMD | 1 Participants |
| Underlying Condition in Study Eye DME Only | 12 Participants |
| Underlying Condition in Study Eye nAMD Only | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 1 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 | 100 Percentage of injection procedures |
| Faricimab PFS Configuration | 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 |
Primary
Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faricimab PFS Configuration | Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration | 0 Percentage of injection procedures |