Open-angle GlaucomaPhase 4NCT02873806
Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
A Phase 4 study testing Implantation of two iStent inject micro-bypass stents, Topical travoprost and Two iStent inject micro-bypass stents in people with Open-angle Glaucoma, run by Glaukos Corporation at 1 site in Armenia.
Trial summary
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation. 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?
- Implantation of two iStent inject micro-bypass stents, Topical travoprost and Two iStent inject micro-bypass stents
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 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)
- C/D ratio ≤ 0.9
- Visual field defects, or nerve abnormality characteristic of glaucoma
- Two topical hypotensive medications at time of screening exam
Show all 14Show fewer
- 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
- A 3mmHg IOP increase over screening mean IOP
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
- Prior incisional glaucoma surgery
Show all 23Show 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.
- 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 that would inhibit visualization of the nasal angle
- Congenital or traumatic cataract
- Retinal or optic nerve disorders 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
- Chronic ocular inflammatory disease or presence of active ocular inflammation
- Baseline Exam Exclusion Criteria:
- Subject did not complete medication washout
- Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
- Subject does not have a 3mmHg IOP increase over screening mean diurnal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
Read the detailed description
The study design is as follows:
- Prospective, single-arm study.
- Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
- Subjects on two topical ocular hypotensive medications (one a prostaglandin).
- Implantation of two iStent inject 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.
- Follow-up through 60 months postoperative (or 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
- Implantation of two iStent inject micro-bypass stents, Topical travoprost, Two iStent inject micro-bypass stents, Tobramycin, Dexamethasone
- 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.
Implantation of two iStent inject micro-bypass stentsProcedure or surgery
Also called iStent inject
- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Topical travoprostDrug
Also called travoprost
- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Two iStent inject micro-bypass stentsDevice
Also called iStent inject
- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
TobramycinDrug
Topical antibiotic (tobramycin):
1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .
DexamethasoneDrug
Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):
- Week 1: 1 drop four (4) times per day in the study eye
- Week 2: 1 drop three (3) times per day in the study eye
- Week 3: 1 drop two (2) times per day in the study eye
- Week 4: 1 drop one (1) time per day in the study eye
| Study group | Role | What they receive |
|---|---|---|
| 2 micro-bypass stents & travoprost | Other | Two iStent inject micro-bypass stents and topical travoprost
Intervention:
* Implantation of two iStent inject micro-bypass stents
* Tobramycin
* Dexamethasone Receives: Procedure: Implantation of two iStent inject micro-bypass stents; Drug: Topical travoprost; Device: Two iStent inject micro-bypass stents; Drug: Tobramycin; Drug: Dexamethasone |
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 versus baseline with reduction of 1 medication
Measured: 12 months postoperative
Secondary outcomes (1)
Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 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 (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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
- NCT02873806
- Sponsor's protocol ID
- GCF-039
- Status last verified
- Sep 2022
- First submitted
- 11 Aug 2016
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.
PubMed 28384377
Study at a glance
From the registry record, last updated by the sponsor on 7 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 Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin
- ClinicalTrials.gov ID
- NCT02873806
- Acronym / sponsor ID
- GCF-039
- Conditions
- Open-angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 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
- 22 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.
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
Detailed description
The study design is as follows:
- Prospective, single-arm study.
- Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
- Subjects on two topical ocular hypotensive medications (one a prostaglandin).
- Implantation of two iStent inject 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.
- Follow-up through 60 months postoperative (or 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 |
|---|---|---|
| 2 micro-bypass stents & travoprost | Other | Procedure: Implantation of two iStent inject micro-bypass stents, Drug: Topical travoprost, Device: Two iStent inject micro-bypass stents, Drug: Tobramycin, Drug: DexamethasoneTwo iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
- C/D ratio ≤ 0.9
- Visual field defects, or nerve abnormality characteristic of glaucoma
- Two topical hypotensive medications at time of screening exam
Key exclusion criteria (23 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
- 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 |
|---|---|---|
| Implantation of two iStent inject micro-bypass stentsAlso: iStent inject- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery). | Procedure or surgery | 2 micro-bypass stents & travoprost |
| Topical travoprostAlso: travoprost- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1. | Drug | 2 micro-bypass stents & travoprost |
| Two iStent inject micro-bypass stentsAlso: iStent inject- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure. | Device | 2 micro-bypass stents & travoprost |
| TobramycinTopical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) . | Drug | 2 micro-bypass stents & travoprost |
| DexamethasoneTopical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): * Week 1: 1 drop four (4) times per day in the study eye * Week 2: 1 drop three (3) times per day in the study eye * Week 3: 1 drop two (2) times per day in the study eye * Week 4: 1 drop one (1) time per day in the study eye | Drug | 2 micro-bypass stents & travoprost |
Primary outcome
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
Time frame: 12 months postoperative
1 secondary outcome
Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication
Time frame: 12 months postoperative
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 7 Sep 2022.
- Background: PubMed 28384377Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.
- Individual participant dataSharing planned: No
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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.
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 Implantation of two iStent inject micro-bypass stents, Topical travoprost and Two iStent inject micro-bypass stents 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 14 inclusion and 23 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 7 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 versus baseline with reduction of 1 medication (time frame: 12 months postoperative). 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 NCT02873806, 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 7 Sep 2022.