Open Angle GlaucomaPhase 4NCT02868190
Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication
A Phase 4 study testing Two trabecular micro-bypass stents (iStent inject) in people with Open Angle Glaucoma, run by Glaukos Corporation at 1 site in Armenia.
Trial summary
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication 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?
- Two trabecular micro-bypass stents (iStent inject)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteArmenia
- Study dates
- Mar 2013to 8 Nov 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening Exam Inclusion Criteria:
- Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs).
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative).
- Cup-to-disc ratio ≤ 0.9.
- Visual field defects, or nerve abnormality characteristic of glaucoma.
- One topical hypotensive medication at time of screening exam.
Show all 13Show fewer
- Intraocular pressure (IOP) > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam.
- Study eye BCVA 20/100 or better.
- Normal angle anatomy as determined by gonioscopy.
- Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent.
- Baseline Exam Inclusion Criteria:
- Subject has completed appropriate medication washout.
- Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period.
Who cannot join
- Screening Exam Exclusion Criteria:
- Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs).
- Prior stent implantations (study eye).
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
- Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma.
- Prior incisional glaucoma surgery.
Show all 24Show fewer
- Prior SLT within 90 days prior to screening.
- Prior ALT.
- Iridectomy or laser iridotomy.
- Ineligibility for ocular hypotensive medication washout period as determined by the investigator such as: visual field status would be placed at risk by washout period, or unmedicated IOP after washout period would be expected to exceed upper limit of ≥ 38 mmHg.
- Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis).
- Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata.
- Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability.
- Corneal opacities or disorders that would inhibit visualization of the nasal angle.
- Congenital or traumatic cataract.
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition.
- Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
- Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.).
- Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis).
- Pregnant or nursing women.
- Baseline Exam Exclusion Criteria:
- Subject did not complete medication washout.
- Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout.
- Subject did not have a 3mmHg IOP increase over screening mean diurnal IOP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication
Read the detailed description
The study design is as follows:
Prospective
Subjects with medicated IOP > 18 mmHg and ≤ 30 mmHg
Subjects on one topical ocular hypotensive medication prior to stent implantation
Implantation of two iStent devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued)
IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP
Diurnal IOP measurements
Follow-up through 60 months postoperative (but could be up to 61 months if subject needs to undergo terminal washout)
Descriptive statistics will be tabulated
Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion
- Conditions
- Open Angle Glaucoma
- Being tested
- Two trabecular micro-bypass stents (iStent inject)
- 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.
Two trabecular micro-bypass stents (iStent inject)Device
Standalone implantation of two trabecular micro-bypass stents (iStent inject)
| Study group | Role | What they receive |
|---|---|---|
| Two micro-bypass stents (iStent inject) | Other | Standalone implantation of two trabecular micro-bypass stents (iStent inject) Receives: Device: Two trabecular micro-bypass stents (iStent inject) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraocular pressure reduction of 20% or more vs baseline
Measured: 12 months post-op
Secondary outcomes (1)
Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg
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 posted16 Aug 2016 (estimated)
- Study startMar 2013
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilit Voskanyan, MD, PhD, Principal investigator, S.V. Malayan Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868190
- Sponsor's protocol ID
- GCF-038
- Status last verified
- Sep 2022
- First submitted
- 11 Aug 2016
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lindstrom R, Lewis R, Hornbeak DM, Voskanyan L, Giamporcaro JE, Hovanesian J, Sarkisian S. Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up. Adv Ther. 2016 Nov;33(11):2082-2090. doi: 10.1007/s12325-016-0420-8. Epub 2016 Oct 13.
PubMed 27739003Lindstrom R, Sarkisian SR, Lewis R, Hovanesian J, Voskanyan L. Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication. Clin Ophthalmol. 2020 Jan 13;14:71-80. doi: 10.2147/OPTH.S235293. eCollection 2020.
PubMed 32021070
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)
- ClinicalTrials.gov ID
- NCT02868190
- Acronym / sponsor ID
- GCF-038
- Conditions
- Open Angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 16 Aug 2016 (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.
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication
Detailed description
The study design is as follows:
Prospective
Subjects with medicated IOP > 18 mmHg and ≤ 30 mmHg
Subjects on one topical ocular hypotensive medication prior to stent implantation
Implantation of two iStent devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued)
IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP
Diurnal IOP measurements
Follow-up through 60 months postoperative (but could be up to 61 months if subject needs to undergo terminal washout)
Descriptive statistics will be tabulated
Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two micro-bypass stents (iStent inject) | Other | Device: Two trabecular micro-bypass stents (iStent inject)Standalone implantation of two trabecular micro-bypass stents (iStent inject) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs).
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative).
- Cup-to-disc ratio ≤ 0.9.
- Visual field defects, or nerve abnormality characteristic of glaucoma.
- One topical hypotensive medication at time of screening exam.
Key exclusion criteria (24 listed)
- Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs).
- Prior stent implantations (study eye).
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
- Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma.
- Prior incisional glaucoma surgery.
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 |
|---|---|---|
| Two trabecular micro-bypass stents (iStent inject)Standalone implantation of two trabecular micro-bypass stents (iStent inject) | Device | Two micro-bypass stents (iStent inject) |
Primary outcome
Mean intraocular pressure reduction of 20% or more vs baseline
Time frame: 12 months post-op
1 secondary outcome
Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg
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 8 Sep 2022.
- Background: PubMed 27739003Lindstrom R, Lewis R, Hornbeak DM, Voskanyan L, Giamporcaro JE, Hovanesian J, Sarkisian S. Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up. Adv Ther. 2016 Nov;33(11):2082-2090. doi: 10.1007/s12325-016-0420-8. Epub 2016 Oct 13.
- Derived from this study: PubMed 32021070Lindstrom R, Sarkisian SR, Lewis R, Hovanesian J, Voskanyan L. Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication. Clin Ophthalmol. 2020 Jan 13;14:71-80. doi: 10.2147/OPTH.S235293. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Open Angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
Lilit Voskanyan, MD, PhD principal investigator
S.V. Malayan Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Two trabecular micro-bypass stents (iStent inject) in people with Open Angle Glaucoma, run by Glaukos Corporation at 1 site in Armenia.
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 13 inclusion and 24 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 8 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 Armenia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean intraocular pressure reduction of 20% or more vs baseline (time frame: 12 months post-op). 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 NCT02868190, which also lists 2 linked publications.
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 8 Sep 2022.