Primary Open Angle Glaucoma (POAG)NCT03478293
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
A study testing iStent inject surgery in people with Primary Open Angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- iStent inject surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2018to 30 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open angle glaucoma (POAG)
- Subject on two ocular hypotensive medications
Who cannot join
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Ophthalmology - UNIFESP/ Hospital São Paulo
São Paulo, 04023-62
About this study
Official title: A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
Read the detailed description
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- iStent inject surgery
- 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.
iStent inject surgeryDevice
Micro-invasive glaucoma surgery (MIGS) to implant iStent inject
| Study group | Role | What they receive |
|---|---|---|
| iStent inject surgery | Experimental | Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject Receives: Device: iStent inject surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction at 12 and 24 months on same number or fewer medications
IOP reduction at 12 and 24 months on same number or fewer medications
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start27 Feb 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Stephens, OD, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478293
- Sponsor's protocol ID
- GCF-045
- Status last verified
- Sep 2022
- First submitted
- 20 Mar 2018
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
- ClinicalTrials.gov ID
- NCT03478293
- Acronym / sponsor ID
- GCF-045
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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 intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
Detailed description
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iStent inject surgery | Experimental | Device: iStent inject surgerySingle-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with primary open angle glaucoma (POAG)
- Subject on two ocular hypotensive medications
Key exclusion criteria (2 listed)
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
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 surgeryMicro-invasive glaucoma surgery (MIGS) to implant iStent inject | Device | iStent inject surgery |
Primary outcome
IOP reduction at 12 and 24 months on same number or fewer medications
Time frame: 12 months and 24 months
IOP reduction at 12 and 24 months on same number or fewer medications
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
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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 director
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStent inject surgery in people with Primary Open Angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Brazil.
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 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 (reason given: Business Decision). 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 at 12 and 24 months on same number or fewer medications (time frame: 12 months and 24 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 9 Sep 2022.