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Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Glaucoma Stent Surgery (GTS400 Stent)
cataract surgery alone
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
  • Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

Not meeting inclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery

    Control Group (Group 2): Cataract surgery only

    Outcomes

    Primary Outcome Measures

    Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
    Percent reaching this endpoint

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2008
    Last Updated
    February 4, 2014
    Sponsor
    Glaukos Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00721968
    Brief Title
    Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
    Official Title
    A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    August 2012 (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
    To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.
    Detailed Description
    The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Control Group (Group 2): Cataract surgery only
    Intervention Type
    Device
    Intervention Name(s)
    Glaucoma Stent Surgery (GTS400 Stent)
    Other Intervention Name(s)
    GTS400 Stent
    Intervention Description
    ab interno trabecular bypass stent surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery alone
    Other Intervention Name(s)
    Phacoemulsification
    Intervention Description
    Cataract surgery alone
    Primary Outcome Measure Information:
    Title
    Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
    Description
    Percent reaching this endpoint
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Number of Ocular Hypotensive Medications by Visit
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form Exclusion Criteria: Not meeting inclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Head of Clinical Affairs
    Organizational Affiliation
    Glaukos Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

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