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Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

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ClinicalTrials.gov Identifier: NCT03639870
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Model iS3 three-stent trabecular micro-bypass system Not Applicable

Detailed Description:
This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The three G2-W stents are heparin-coated and manufactured from implant grade titanium.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Implant Group
Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative.
Device: Model iS3 three-stent trabecular micro-bypass system
Provided in Arm/Group descriptions.
Other Name: Implant Group




Primary Outcome Measures :
  1. Primary effectiveness endpoint [ Time Frame: Month 12 postoperative ]
    The change in mean diurnal IOP from baseline at 12 months



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
  • Phakic or pseudophakic.
  • Males or females, 45 years of age or older.

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
  • Active corneal inflammation or edema.
  • Retinal disorders not associated with glaucoma.

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): NCT03639870


Contacts
Contact: Abhi Vilupuru, PhD, BS (Optom) 9493679600 avilupuru@glaukos.com

Locations
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Steven Sarkisian, MD         
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Nicholas Tarantino, O.D. Glaukos Corporation

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT03639870     History of Changes
Other Study ID Numbers: INFI-106-G2W3 (GC-011)
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Glaukos Corporation:
refractory

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases