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

NCT03639870 | Unknown DMC FDA Device

• 1 other identifier: INFI-106-G2W3 (GC-011)
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

refractory

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness endpoint

  The change in mean diurnal IOP from baseline at 12 months

  Month 12 postoperative

Study Arms (1)

Implant Group

EXPERIMENTAL

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

Interventions

Model iS3 three-stent trabecular micro-bypass system DEVICE

Provided in Arm/Group descriptions.

Also known as: Implant Group

Implant Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaucoma Associates of Tx

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Kerry Stephens, O.D.

  Glaukos Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: July 10, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)