GlaucomaPhase 3NCT01052558
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
A Phase 3 study testing iStent Inject (GTS400) and Cataract Surgery in people with Glaucoma, run by Glaukos Corporation at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- iStent Inject (GTS400) and Cataract Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 22 sitesUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pseudoexfoliative and pigmentary glaucoma
- Prior glaucoma surgery of any type
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Texan Eye
Austin, Texas, 78731
Laurel Eye Clinic
Brookville, Pennsylvania, 15825
Thomas Mundorf, MD
Charlotte, North Carolina, 28204
Chicago Eye Specialists
Chicago, Illinois, 60619
Kresge Eye Institute
Detroit, Michigan, 48201
Las Vegas Physician Research Group
Henderson, Nevada, 75965
Discover Vision Centers
Independence, Missouri, 64055
Whitson Vision, PC
Indianapolis, Indiana, 46240
Silverstein Eye Centers
Kansas City, Missouri, 64133
D'Ambrosio Eye Care
Lancaster, Massachusetts, 01523
Shepherd Eye Center
Las Vegas, Nevada, 89121
The Center for Excellence in Eye Care
Miami, Florida, 33176
Clayton Eye Center / Eye Care Centers Management, Inc.
Morrow, Georgia, 30260
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
Lehmann Eye Center
Nacogdoches, Texas, 75965
Glaucoma Consultants of Colorado
Parker, Colorado, 80134
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, 72756
Vance Thompson Vision / Sanford Clinic
Sioux Falls, South Dakota, 57105
St. John's Medical Research Institute
Springfield, Missouri, 65807
International Eye Center
Tampa, Florida, 33603
About this study
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
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- iStent Inject (GTS400), Cataract Surgery
- Keywords
- Open angle, Glaucoma, Cataract, Surgery, Intraocular Pressure
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent Inject (GTS400)Device
Also called Cataract surgery, stent implantation
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
Cataract SurgeryProcedure or surgery
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
| Study group | Role | What they receive |
|---|---|---|
| Cataract Surgery Only | Active comparator | Not described Receives: Procedure: Cataract Surgery |
| Treatment with Cataract Surgery & Stents | Experimental | Ab interno trabecular micro-bypass stent surgery Receives: Device: iStent Inject (GTS400) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Wells, PharmD, MBA, Study director, Glaukos CorporationJay Katz, MD, Study chair, Wills Eye Institute; Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052558
- Sponsor's protocol ID
- GC-006
- Status last verified
- May 2015
- First submitted
- 13 Jan 2010
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01052558
- Acronym / sponsor ID
- GC-006
- Conditions
- Glaucoma
- Keywords
- Open angle, Glaucoma, Cataract, Surgery, Intraocular Pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgery Only | Active comparator | Procedure: Cataract Surgery |
| Treatment with Cataract Surgery & Stents | Experimental | Device: iStent Inject (GTS400)Ab interno trabecular micro-bypass stent surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pseudoexfoliative and pigmentary glaucoma
- Prior glaucoma surgery of any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStent Inject (GTS400)Also: Cataract surgery, stent implantationSubjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents. | Device | Treatment with Cataract Surgery & Stents |
| Cataract SurgerySubjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only. | Procedure or surgery | Cataract Surgery Only |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Wells, PharmD, MBA study director
Glaukos Corporation
Jay Katz, MD study chair
Wills Eye Institute; Thomas Jefferson University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iStent Inject (GTS400) and Cataract Surgery in people with Glaucoma, run by Glaukos Corporation at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.