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)

NCT02698566 | Completed Phase 3 Results

• 1 other identifier: GX30020
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Ranibizumab PFS

EXPERIMENTAL

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

Interventions

Ranibizumab DRUG

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

Also known as: Lucentis

Ranibizumab PFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ocular
• Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the retina specialist

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Southeastern Retina Associates

Chattanooga, Tennessee, 37421, United States

Location

Charles Retina Institution

Germantown, Tennessee, 38138, United States

Location

Related Publications (1)

• 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.

  PMID: 29853609 DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: March 21, 2016
• Primary Completion: April 5, 2016
• Study Completion: April 5, 2016
• Last Updated: September 21, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-08

Locations

US (4)