Macular Edema
Conditions
Brief summary
This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.
Detailed description
The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.
Interventions
DRUGRanibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ocular * Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist
Exclusion criteria
Concurrent Ocular Conditions * Patients legally blind in one or both eyes * 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 uveitis, or sterile inflammatory reaction after the past ITV injections with any agent * Active disorder of ocular adnexa and skin in the study eye, including ocular surface infections * History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after ITV injection or intraocular procedures * Uncontrolled intraocular pressure greater than (\>) 25 millimeters of mercury (mmHg) in the study eye (uncontrolled means that it occurs even with intraocular pressure-lowering therapy) * Use of therapies that are known to be toxic to any ocular tissues within the 6 months prior to enrollment Prior Ocular Therapies * Treatment with any ITV injection 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 past 3 months General * Receipt of any systemic (non-ocular) investigational drug within 3 months prior to Day 1 * Current systemic coagulation or bleeding disorders and history of recurrent hemorrhages * Intolerance or known reaction to prior biological therapies * History of other diseases or physical or laboratory examination findings that per the retina specialist represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk. * Uncontrolled hypertension (systolic \>160 mmHg and/or diastolic \>100 mmHg while sitting) * Current systemic infectious disease or a therapy for active infectious disease * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Task Completions | Day 1 | Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion. |
| Percentage of PFS Usage Errors on Safety Critical Tasks | Day 1 | Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm. |
| Percentage of PFS Usage Errors on Essential Tasks | Day 1 | Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product. |
Countries
United States
Participant flow
Pre-assignment details
Participant Flow module includes the number of patients enrolled (35) as well as the number of healthcare professionals (3) who administered intravitreal (ITV) injections to enrolled patients.
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab PFS HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Ranibizumab PFS |
|---|---|
| Age, Continuous | 78.3 years STANDARD_DEVIATION 6.8 |
| Sex/Gender, Customized Female | 0 patients |
| Sex/Gender, Customized Male | 0 patients |
| Sex/Gender, Customized Unknown | 35 patients |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Percentage of PFS Usage Errors on Essential Tasks
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.
Time frame: Day 1
Population: Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab PFS | Percentage of PFS Usage Errors on Essential Tasks | 0 percentage of usage errors |
Primary
Percentage of PFS Usage Errors on Safety Critical Tasks
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.
Time frame: Day 1
Population: Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab PFS | Percentage of PFS Usage Errors on Safety Critical Tasks | 0 percentage of usage errors |
Primary
Percentage of Successful Task Completions
Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.
Time frame: Day 1
Population: Three HCPs referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab PFS | Percentage of Successful Task Completions | Open the carton | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Remove contents from carton | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Peel the lid off the blister pack | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Carefully remove the PFS using aseptic technique | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Snap off PFS cap | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Firmly screw needle onto the Luer lock of PFS | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Remove needle cap | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Dose preparation: aligning stopper with dose line | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Insert PFS at injection site | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Slowly inject full dose | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Remove PFS from injection site | 100 percentage of tasks |
| Ranibizumab PFS | Percentage of Successful Task Completions | Dispose of used PFS and needle | 100 percentage of tasks |