Back to resultsA 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)
Primary Purpose
Macular Edema
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional other trial for Macular Edema
Eligibility Criteria
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
Sites / Locations
- Paducah Retinal Center
- Char Eye Ear &Throat Assoc
- Southeastern Retina Associates
- Charles Retina Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab PFS
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02698566
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
April 5, 2016 (Actual)
Study Completion Date
April 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab PFS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Primary Outcome Measure Information:
Title
Percentage of Successful Task Completions
Description
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
Title
Percentage of PFS Usage Errors on Safety Critical Tasks
Description
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
Title
Percentage of PFS Usage Errors on Essential Tasks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Char Eye Ear &Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Southeastern Retina Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Charles Retina Institution
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29853609
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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