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)

August 23, 2017 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Southeastern Retina Associates
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2016

Primary Completion (Actual)

April 5, 2016

Study Completion (Actual)

April 5, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX30020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Edema

Clinical Trials on Ranibizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe