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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
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Macular Edema Drug: Ranibizumab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
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.
Drug: Ranibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
Other Name: Lucentis




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02698566    
Other Study ID Numbers: GX30020
First Posted: March 3, 2016    Key Record Dates
Results First Posted: July 26, 2017
Last Update Posted: September 21, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents