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)

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698566
• Other study ID #: GX30020
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2016
• Last updated: August 23, 2017
• Start date: March 21, 2016
• Est. completion date: April 5, 2016

Study information

• Verified date: August 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 5, 2016
• Est. primary completion date: April 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab
Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.

Locations

Country	Name	City	State
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Southeastern Retina Associates	Chattanooga	Tennessee
United States	Charles Retina Institution	Germantown	Tennessee
United States	Paducah Retinal Center	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1
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.	Day 1
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.	Day 1