Open-angle GlaucomaPhase 3NCT00721968
Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
A Phase 3 study testing Glaucoma Stent Surgery (GTS400 Stent) and cataract surgery alone in people with Open-angle Glaucoma, run by Glaukos Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- Glaucoma Stent Surgery (GTS400 Stent) and cataract surgery alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
About this study
Official title: A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
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.
Read the 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.
- Conditions
- Open-angle Glaucoma
- Being tested
- Glaucoma Stent Surgery (GTS400 Stent), cataract surgery alone
- Keywords
- Open angle, Glaucoma, Cataract, Surgery
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma Stent Surgery (GTS400 Stent)Device
Also called GTS400 Stent
ab interno trabecular bypass stent surgery
cataract surgery aloneProcedure or surgery
Also called Phacoemulsification
Cataract surgery alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery Receives: Device: Glaucoma Stent Surgery (GTS400 Stent) |
| 2 | Placebo comparator | Control Group (Group 2): Cataract surgery only Receives: Procedure: cataract surgery alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
Percent reaching this endpoint
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 posted25 Jul 2008 (estimated)
- Study startMar 2007
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open-angle 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Affairs, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721968
- Sponsor's protocol ID
- GC-005
- Status last verified
- Feb 2014
- First submitted
- 23 Jul 2008
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
- ClinicalTrials.gov ID
- NCT00721968
- Acronym / sponsor ID
- GC-005
- Conditions
- Open-angle Glaucoma
- Keywords
- Open angle, Glaucoma, Cataract, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Glaucoma Stent Surgery (GTS400 Stent)Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery |
| 2 | Placebo comparator | Procedure: cataract surgery aloneControl Group (Group 2): Cataract surgery only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Glaucoma Stent Surgery (GTS400 Stent)Also: GTS400 Stentab interno trabecular bypass stent surgery | Device | 1 |
| cataract surgery aloneAlso: PhacoemulsificationCataract surgery alone | Procedure or surgery | 2 |
Primary outcome
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
Time frame: 12 months
Percent reaching this endpoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Head of Clinical Affairs study director
Glaukos Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glaucoma Stent Surgery (GTS400 Stent) and cataract surgery alone in people with Open-angle Glaucoma, run by Glaukos Corporation.
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 2 inclusion and 1 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications (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 6 Mar 2014.