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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab PFS | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 |
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Inclusion Criteria:
Ocular
Exclusion Criteria:
Concurrent Ocular Conditions
Prior Ocular Therapies
General
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States | ||
| Char Eye Ear &Throat Assoc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29853609 | Derived | Antoszyk AN, Baker C, Calzada J, Cummings H, So J, Quezada-Ruiz C, Haskova Z. Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):411-419. doi: 10.5731/pdajpst.2017.008342. Epub 2018 May 31. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Ranibizumab PFS - HCPs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Charlotte |
| North Carolina |
| 28210 |
| United States |
| Southeastern Retina Associates | Chattanooga | Tennessee | 37421 | United States |
| Charles Retina Institution | Germantown | Tennessee | 38138 | United States |
HCPs administered ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Gender information was not collected for this study. | Number | patients |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of tasks | Day 1 | ITV injections | ITV injections |
|
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| 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. | 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. | Posted | Number | percentage of usage errors | Day 1 | ITV injections | ITV injections |
|
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| 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. | 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. | Posted | Number | percentage of usage errors | Day 1 | ITV injections | ITV injections |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 35 | 1 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Unknown |
|
| Title | Measurements |
|---|---|
|
| Carefully remove the PFS using aseptic technique |
|
| Snap off PFS cap |
|
| Firmly screw needle onto the Luer lock of PFS |
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| Remove needle cap |
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| Dose preparation: aligning stopper with dose line |
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| Insert PFS at injection site |
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| Slowly inject full dose |
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| Remove PFS from injection site |
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| Dispose of used PFS and needle |
|
| ITV injections |
|
|
| ITV injections |
|
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