A Phase 3 interventional study of Ranibizumab in Macular Edema, sponsored by Genentech, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-21.
Sponsored by Genentech, Inc. · Phase 3, Interventional, and Other
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 35 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Ocular
Exclusion Criteria:
Concurrent Ocular Conditions
Prior Ocular Therapies
General
Healthcare professionals (HCPs) will administer ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
Drug: Ranibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Also known as: Lucentis
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
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
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
| Milestone | Ranibizumab PFS - Patients | Ranibizumab PFS - HCPs |
|---|---|---|
| Started | 35 | 3 |
| Completed | 35 | 3 |
| Not completed | 0 | 0 |
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 tasks | Ranibizumab PFS |
|---|---|
| Open the carton | 100 |
| Remove contents from carton | 100 |
| Peel the lid off the blister pack | 100 |
| Carefully remove the PFS using aseptic technique | 100 |
| Snap off PFS cap | 100 |
| Firmly screw needle onto the Luer lock of PFS | 100 |
| Remove needle cap | 100 |
| Dose preparation: aligning stopper with dose line | 100 |
| Insert PFS at injection site | 100 |
| Slowly inject full dose | 100 |
| Remove PFS from injection site | 100 |
| Dispose of used PFS and needle | 100 |
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 usage errors | Ranibizumab PFS |
|---|---|
| Percentage of PFS Usage Errors on Safety Critical Tasks | 0 |
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.
| percentage of usage errors | Ranibizumab PFS |
|---|---|
| Percentage of PFS Usage Errors on Essential Tasks | 0 |
Collected over Day 1 to Day 7. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranibizumab PFS | — | 0/35 (0%) | 1/35 (2.9%) |
| Event | Ranibizumab PFS |
|---|---|
| Conjunctival hemorrhageEye disorders | 1/35 |
All enrolled patients.
| Age, Continuous(years) | Ranibizumab PFS |
|---|---|
| Mean | 78.3 ± 6.8 |
| Sex/Gender, Customized(patients) | Ranibizumab PFS |
|---|---|
| Female | 0 |
| Male | 0 |
| Unknown | 35 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.