Primary Open-Angle GlaucomaNCT02327312
Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
A study testing Stents, Laser and Laser Trabeculoplasty in people with Primary Open-Angle Glaucoma, run by Glaukos Corporation at 9 sites in United States.
Trial summary
To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma
- What is being tested?
- Stents, Laser and Laser Trabeculoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Dec 2014to 11 Aug 2020
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open angle Glaucoma
Who cannot join
- Active corneal inflammation or edema
- Choroidal detachment, effusion, choroiditis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Cape Coral, Florida, 33904
Study site
Elizabeth City, North Carolina, 27909
Study site
Fayetteville, Arkansas, 72704
Study site
Fort Worth, Texas, 76102
Study site
Glendale, Arizona, 85306
Study site
Hemet, California, 92545
Study site
Memphis, Tennessee, 38120
Study site
Racine, Wisconsin, 53405
Study site
San Antonio, Texas, 78229
About this study
To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma
- Conditions
- Primary Open-Angle Glaucoma
- Being tested
- Stents, Laser, Laser Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentsDevice
Two Trabecular meshwork Micro-Bypass stents into the study eye
LaserProcedure or surgery
Laser Trabeculoplasty
Laser TrabeculoplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Implantation of two Trabecular Meshwork stents into the study eye Receives: Device: Stents |
| Laser | Active comparator | Laser Trabeculoplasty Receives: Procedure: Laser; Device: Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction
Measured: up to 24 months
Secondary outcomes (1)
% IOP reduction
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study start16 Dec 2014
- Primary completion31 May 2019
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Stephens, OD, Study chair, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327312
- Sponsor's protocol ID
- GC-004
- Status last verified
- Dec 2022
- First submitted
- 6 Nov 2014
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
- ClinicalTrials.gov ID
- NCT02327312
- Acronym / sponsor ID
- GC-004
- Conditions
- Primary Open-Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 30 Dec 2014 (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.
To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | Experimental | Device: StentsImplantation of two Trabecular Meshwork stents into the study eye |
| Laser | Active comparator | Procedure: Laser, Device: Laser TrabeculoplastyLaser Trabeculoplasty |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Open angle Glaucoma
Key exclusion criteria (2 listed)
- Active corneal inflammation or edema
- Choroidal detachment, effusion, choroiditis
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 |
|---|---|---|
| StentsTwo Trabecular meshwork Micro-Bypass stents into the study eye | Device | Surgical |
| LaserLaser Trabeculoplasty | Procedure or surgery | Laser |
| Laser Trabeculoplasty | Device | Laser |
Primary outcome
IOP reduction
Time frame: up to 24 months
1 secondary outcome
% IOP reduction
Time frame: up to 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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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.
Kerry Stephens, OD study chair
Glaukos Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stents, Laser and Laser Trabeculoplasty in people with Primary Open-Angle Glaucoma, run by Glaukos Corporation at 9 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 1 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: stopped early, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
IOP reduction (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327312, which also lists 1 linked publication.
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 22 Dec 2022.