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GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
iStent Inject (GTS400)
Cataract Surgery
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Open angle, Glaucoma, Cataract, Surgery, Intraocular Pressure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma in the study eye
  • Subject must be on 1 to 3 glaucoma medications
  • Subject able and willing to attend follow up visits for two years postop
  • Subject able and willing to sign informed consent

Exclusion Criteria:

  • Pseudoexfoliative and pigmentary glaucoma
  • Prior glaucoma surgery of any type

Sites / Locations

  • Boozman-Hof Regional Eye Clinic
  • North Bay Eye Associates, Inc.
  • Glaucoma Consultants of Colorado
  • The Center for Excellence in Eye Care
  • International Eye Center
  • Clayton Eye Center / Eye Care Centers Management, Inc.
  • Chicago Eye Specialists
  • Whitson Vision, PC
  • D'Ambrosio Eye Care
  • Kresge Eye Institute
  • Discover Vision Centers
  • Silverstein Eye Centers
  • St. John's Medical Research Institute
  • Las Vegas Physician Research Group
  • Shepherd Eye Center
  • Ophthalmic Consultants of Long Island
  • Thomas Mundorf, MD
  • Laurel Eye Clinic
  • Carolina Eyecare Physicians
  • Vance Thompson Vision / Sanford Clinic
  • Texan Eye
  • Lehmann Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cataract Surgery Only

Treatment with Cataract Surgery & Stents

Arm Description

Ab interno trabecular micro-bypass stent surgery

Outcomes

Primary Outcome Measures

Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2010
Last Updated
May 18, 2015
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01052558
Brief Title
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
Official Title
A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
Detailed Description
Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Open angle, Glaucoma, Cataract, Surgery, Intraocular Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cataract Surgery Only
Arm Type
Active Comparator
Arm Title
Treatment with Cataract Surgery & Stents
Arm Type
Experimental
Arm Description
Ab interno trabecular micro-bypass stent surgery
Intervention Type
Device
Intervention Name(s)
iStent Inject (GTS400)
Other Intervention Name(s)
Cataract surgery, stent implantation
Intervention Description
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
Primary Outcome Measure Information:
Title
Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with open-angle glaucoma in the study eye Subject must be on 1 to 3 glaucoma medications Subject able and willing to attend follow up visits for two years postop Subject able and willing to sign informed consent Exclusion Criteria: Pseudoexfoliative and pigmentary glaucoma Prior glaucoma surgery of any type
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Wells, PharmD, MBA
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jay Katz, MD
Organizational Affiliation
Wills Eye Institute; Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Boozman-Hof Regional Eye Clinic
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72756
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Glaucoma Consultants of Colorado
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
The Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
International Eye Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clayton Eye Center / Eye Care Centers Management, Inc.
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Chicago Eye Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
Whitson Vision, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
D'Ambrosio Eye Care
City
Lancaster
State/Province
Massachusetts
ZIP/Postal Code
01523
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
St. John's Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Las Vegas Physician Research Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
75965
Country
United States
Facility Name
Shepherd Eye Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Thomas Mundorf, MD
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Laurel Eye Clinic
City
Brookville
State/Province
Pennsylvania
ZIP/Postal Code
15825
Country
United States
Facility Name
Carolina Eyecare Physicians
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Vance Thompson Vision / Sanford Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States

12. IPD Sharing Statement

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GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

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