Open Angle GlaucomaPhase 4POAGNCT07228221
Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
A Phase 4 study testing iStent infinite trabecular micro-bypass system model iS3 and iDose TR (Travoprost intracameral Implant) 75mcg in people with Open Angle Glaucoma and Pigmentary Glaucoma, run by Jonathon Myers at 1 site in United States.
Trial summary
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled 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, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- iStent infinite trabecular micro-bypass system model iS3 and iDose TR (Travoprost intracameral Implant) 75mcg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 31 Dec 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
- Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
- Visual acuity HM or better
- VF MD -6dB or worse
- Failed medical therapy and/or laser treatment
- Incisional glaucoma surgery contemplated as next intervention
- Phakic or pseudophakic
Who cannot join
- Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
- Previous incisional glaucoma surgery
- ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
- Active ocular inflammation or edema, clinically significant corneal dystrophy
- Corneal or other pathology preventing accurate Goldmann applanation tonometry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wills Eye Hosital Glaucoma Dept.
Philadelphia, Pennsylvania, 19107
Meskerem Divers, (215)825-4712, mdivers@willseye.org
Jeanne Molineaux, COA, (215)825-4713, jmolineaux@willseye.org
About this study
Official title: iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
Read the detailed description
The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.
- Being tested
- iStent infinite trabecular micro-bypass system model iS3, iDose TR (Travoprost intracameral Implant) 75mcg
- Keywords
- POAG, PG, PXG
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent infinite trabecular micro-bypass system model iS3Device
surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
iDose TR (Travoprost intracameral Implant) 75mcgDrug
surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
| Study group | Role | What they receive |
|---|---|---|
| Surgery for patients with medically uncontrolled POAG | Experimental | surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg Receives: Device: iStent infinite trabecular micro-bypass system model iS3; Drug: iDose TR (Travoprost intracameral Implant) 75mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction from baseline
a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.
Measured: Diurnal IOP reduction from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Jan 2026 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonathon Myers
- Sponsor type
- University, hospital or other
- Collaborators
- Glaukos Corporation
- Responsible party
- Sponsor-investigator, Jonathon Myers, Wills Eye
- Investigators
- Dilru Amarasekera, MD, Principal investigator, Wills Eye Hospital Glaucoma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228221
- Sponsor's protocol ID
- WEH IRB #2025-51
- Acronym
- POAG
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data will be kept on file at Wills Eye Hospital for 7 years. Researchers can request this data by email to glaucoma@willseye.org with a description of their planned use.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)
- ClinicalTrials.gov ID
- NCT07228221
- Acronym / sponsor ID
- POAG / WEH IRB #2025-51
- Keywords
- POAG, PG, PXG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jonathon MyersUniversity, hospital or other
- Collaborators
- Glaukos Corporation
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 30 Aug 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Nov 2025 (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 Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
Detailed description
The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg
| Arm | Type | Receives |
|---|---|---|
| Surgery for patients with medically uncontrolled POAG | Experimental | Device: iStent infinite trabecular micro-bypass system model iS3, Drug: iDose TR (Travoprost intracameral Implant) 75mcgsurgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
- Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
- Visual acuity HM or better
- VF MD -6dB or worse
- Failed medical therapy and/or laser treatment
Key exclusion criteria (5 listed)
- Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
- Previous incisional glaucoma surgery
- ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
- Active ocular inflammation or edema, clinically significant corneal dystrophy
- Corneal or other pathology preventing accurate Goldmann applanation tonometry
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 infinite trabecular micro-bypass system model iS3surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3 | Device | Surgery for patients with medically uncontrolled POAG |
| iDose TR (Travoprost intracameral Implant) 75mcgsurgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg | Drug | Surgery for patients with medically uncontrolled POAG |
Primary outcome
IOP reduction from baseline
Time frame: Diurnal IOP reduction from baseline at 12 months
a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Yes. The study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data will be kept on file at Wills Eye Hospital for 7 years. Researchers can request this data by email to glaucoma@willseye.org with a description of their planned use.
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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.
Dilru Amarasekera, MD principal investigator
Wills Eye Hospital Glaucoma Research
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 iStent infinite trabecular micro-bypass system model iS3 and iDose TR (Travoprost intracameral Implant) 75mcg in people with Open Angle Glaucoma and Pigmentary Glaucoma, run by Jonathon Myers at 1 site 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. 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 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meskerem Divers (215-825-4712, mdivers@willseye.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP reduction from baseline (time frame: Diurnal IOP reduction from baseline at 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 14 Nov 2025.