Back to resultsA Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra (GCF-041)
Primary Purpose
Glaucoma, Open-Angle
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
G2 and G3
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg
Exclusion Criteria:
- Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200
Sites / Locations
- Prof. Dr. med. Carl Erb
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
G2 and G3 implantation
Arm Description
Two iStent inject stents and one iStent Supra stent
Outcomes
Primary Outcome Measures
20% IOP reduction
IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg
Secondary Outcome Measures
IOP less than or equal to 18 mm Hg
IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255798
Brief Title
A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra
Acronym
GCF-041
Official Title
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
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
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra
Detailed Description
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
G2 and G3
Masking
None (Open Label)
Masking Description
IOP outcome is masked
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G2 and G3 implantation
Arm Type
Other
Arm Description
Two iStent inject stents and one iStent Supra stent
Intervention Type
Device
Intervention Name(s)
G2 and G3
Intervention Description
Two iStent inject devices and one iStent supra device
Primary Outcome Measure Information:
Title
20% IOP reduction
Description
IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
IOP less than or equal to 18 mm Hg
Description
IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg
Exclusion Criteria:
Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, OD
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Prof. Dr. med. Carl Erb
City
Berlin
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra
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