Trial Outcomes & Findings for A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS) (NCT NCT02698566)
NCT ID: NCT02698566
Last Updated: 2017-09-21
Results Overview
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.
COMPLETED
PHASE3
35 participants
Day 1
2017-09-21
Participant Flow
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.
Participant milestones
| Measure |
Ranibizumab PFS - Patients
Healthcare professionals (HCPs) administered ITV injections of ranibizumab 0.5 milligrams (mg) delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
Ranibizumab PFS - HCPs
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
3
|
|
Overall Study
COMPLETED
|
35
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)
Baseline characteristics by cohort
| Measure |
Ranibizumab PFS
n=35 Participants
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|
|
Age, Continuous
|
78.3 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
0 patients
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
0 patients
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
35 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Ranibizumab PFS
n=35 ITV injections
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|
|
Percentage of Successful Task Completions
Open the carton
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Remove contents from carton
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Peel the lid off the blister pack
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Carefully remove the PFS using aseptic technique
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Snap off PFS cap
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Firmly screw needle onto the Luer lock of PFS
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Remove needle cap
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Dose preparation: aligning stopper with dose line
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Insert PFS at injection site
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Slowly inject full dose
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Remove PFS from injection site
|
100 percentage of tasks
|
|
Percentage of Successful Task Completions
Dispose of used PFS and needle
|
100 percentage of tasks
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Ranibizumab PFS
n=35 ITV injections
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|
|
Percentage of PFS Usage Errors on Safety Critical Tasks
|
0 percentage of usage errors
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Ranibizumab PFS
n=35 ITV injections
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|
|
Percentage of PFS Usage Errors on Essential Tasks
|
0 percentage of usage errors
|
Adverse Events
Ranibizumab PFS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranibizumab PFS
n=35 participants at risk
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
|
|---|---|
|
Eye disorders
Conjunctival hemorrhage
|
2.9%
1/35 • Day 1 to Day 7
No safety analyses were pre-specified as objectives in study GX30020. However, in accordance with Good Clinical Practices (GCP) guidelines, adverse events and serious adverse events that occurred during the 7-day study-reporting period were monitored and reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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