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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02698566|
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : July 26, 2017
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Macular Edema||Drug: Ranibizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion to Evaluate the Usability of Lucentis® 0.5 mg Prefilled Syringe|
|Actual Study Start Date :||March 21, 2016|
|Actual Primary Completion Date :||April 5, 2016|
|Actual Study Completion Date :||April 5, 2016|
Experimental: Ranibizumab PFS
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.
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Other Name: Lucentis
- Percentage of Successful Task Completions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698566
|United States, Kentucky|
|Paducah Retinal Center|
|Paducah, Kentucky, United States, 42001|
|United States, North Carolina|
|Char Eye Ear &Throat Assoc|
|Charlotte, North Carolina, United States, 28210|
|United States, Tennessee|
|Southeastern Retina Associates|
|Chattanooga, Tennessee, United States, 37421|
|Charles Retina Institution|
|Germantown, Tennessee, United States, 38138|
|Study Director:||Clinical Trials||Genentech, Inc.|