iStent Infinite Device for Glaucoma

Overseen By Kerry Stephens

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaukos Corporation

Disqualifiers: Traumatic glaucoma, Uveitic glaucoma, Neovascular glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

245 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the iStent Infinite treatment for glaucoma?

Research shows that the iStent Infinite device effectively lowers eye pressure in patients with open angle glaucoma, especially when other treatments haven't worked. It also has a good safety record, reducing the need for additional eye pressure medications. ^{1 2 3 4 5}

Is the iStent Infinite device safe for use in humans?

The iStent Infinite device has been shown to have a favorable safety profile in patients with open-angle glaucoma, and similar devices like the iStent and iStent inject have been evaluated for safety in combination with cataract surgery, showing positive safety results. ^{1 2 6 7 8}

How is the iStent Infinite treatment different from other glaucoma treatments?

The iStent Infinite is unique because it is a minimally invasive device that creates a bypass in the eye's drainage system to lower eye pressure, unlike traditional treatments that often rely on medications or more invasive surgeries. It is implanted through a small incision and allows fluid to drain directly, reducing the need for eye pressure-lowering drugs. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for adults aged 35 or older with mild to moderate primary open-angle glaucoma. It's suitable for those who haven't had success with standard treatments and are either phakic (natural lens present) or pseudophakic (artificial lens implanted). People with other types of glaucoma, active corneal issues, or unrelated retinal disorders cannot participate.

Inclusion Criteria

You have had cataract surgery or have an artificial lens in your eye.

I am 35 years old or older.

I have been diagnosed with primary open-angle glaucoma.

Exclusion Criteria

I have a retinal disorder not related to glaucoma.

I have active inflammation or swelling in my cornea.

My glaucoma is caused by trauma, inflammation, abnormal blood vessels, or a specific eye structure issue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iStent Infinite Trabecular Micro-Bypass System

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person)

Treatment Details

Interventions

• iStent Infinite

Trial Overview The study is testing the iStent Infinite device in a single group of participants without comparing it to another treatment. This device is designed to help reduce eye pressure in patients by improving fluid drainage from the eyes.

Participant Groups

Group I: iStent Infinite Experimental Treatment 1 Intervention

iStent Infinite Trabecular Micro-Bypass System

iStent Infinite is already approved in United States for the following indications:

Approved in United States as iStent infinite for:

• Primary open-angle glaucoma in adult patients who have failed previous medical and surgical treatment

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

The iStent Infinite Trabecular Micro-Bypass System effectively reduced mean diurnal intraocular pressure (MDIOP) in 76.1% of patients with open angle glaucoma (OAG) who had not responded to previous treatments, demonstrating significant efficacy after 12 months.

The procedure showed a favorable safety profile, with no serious complications such as infections or device-related issues, indicating it is a safe option for patients with uncontrolled OAG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma. Sarkisian, SR., Grover, DS., Gallardo, MJ., et al.[2023]

In a study involving 505 participants with mild to moderate primary open-angle glaucoma, the iStent inject Trabecular Micro-Bypass System significantly reduced intraocular pressure (IOP) by an average of 7.0 mmHg compared to 5.4 mmHg in the control group after 24 months, demonstrating its effectiveness when combined with cataract surgery.

The safety profile of the iStent inject was favorable, with no significant differences in adverse events compared to the control group, indicating that it can be safely used alongside cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results. Samuelson, TW., Sarkisian, SR., Lubeck, DM., et al.[2022]

The iStent trabecular micro-bypass system effectively reduces intraocular pressure (IOP) in glaucoma patients, demonstrating safety and efficacy in multiple prospective clinical trials.

This device allows for direct drainage of aqueous humor into Schlemm's canal, bypassing the obstructed trabecular meshwork, and can reduce or eliminate the need for ocular antihypertensive medications, especially when used during cataract surgery or in patients unresponsive to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaukos iStent Trabecular Micro-Bypass. Nichamin, LD.[2022]

Standalone trabecular micro-bypass glaucoma surgery using iStent devices leads to a significant reduction in intraocular pressure (IOP) by approximately 31.1% within 6 to 12 months, and this effect is sustained over longer periods, with reductions of 30.4% to 32.9% at 36 to 60 months.

The procedure also reduces the need for glaucoma medications by about 1.0 to 1.2 medications over the same time frames, while maintaining a safety profile comparable to standard medical therapies, with no significant increase in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone iStent Trabecular Micro-bypass Glaucoma Surgery: A Systematic Review and Meta-Analysis. Healey, PR., Clement, CI., Kerr, NM., et al.[2021]

The iStent trabecular micro-bypass stent significantly reduced intraocular pressure in patients with open angle glaucoma, dropping from an average of 19.6 mmHg preoperatively to 15.8 mmHg after one year, indicating its effectiveness in managing this condition.

The procedure was safe, with no vision-threatening complications reported, and it also led to a decrease in the number of glaucoma medications needed, from an average of 2.7 to 1.7 medications over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The iStent trabecular micro-bypass stent: a case series. Vandewalle, E., Zeyen, T., Stalmans, I.[2022]

The iStent glaucoma device significantly reduced intraocular pressure (IOP) in patients with secondary open-angle glaucoma, with an average decrease of 10.4 mmHg at three months and sustained reductions at six and twelve months (P < 0.05).

Patients also experienced a significant reduction in the number of glaucoma medications needed, decreasing by an average of 1.1 medications at three, six, and twelve months (P < 0.05), indicating that iStent effectively lowers treatment burden without compromising visual acuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year analysis of the iStent trabecular microbypass in secondary glaucoma. Buchacra, O., Duch, S., Milla, E., et al.[2022]

In a study of 73 eyes with open-angle glaucoma undergoing cataract surgery, both the iStent and iStent inject devices significantly reduced intraocular pressure (IOP) and medication use after 6 months, with over 70% of eyes becoming medication-free.

The iStent inject device showed greater effectiveness, achieving a larger reduction in IOP compared to the iStent device, and had fewer adverse events, indicating it may be a safer and more effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a Real-World Setting: A Longitudinal Retrospective Study. Guedes, RAP., Gravina, DM., Lake, JC., et al.[2020]

In a study of 137 eyes with mild to moderate glaucoma undergoing cataract surgery, both iStent and iStent inject significantly reduced intraocular pressure (IOP) over 12 months, with iStent inject showing a greater reduction (6.0 mmHg) compared to iStent (4.2 mmHg).

Both devices led to a substantial decrease in the need for glaucoma medications, with 92.9% of iStent inject patients being medication-free at 12 months compared to 76.1% of iStent patients, while maintaining a favorable safety profile with few adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery. Manning, D.[2021]

The iStent trabecular micro-bypass stent, when implanted during cataract surgery, significantly reduced the need for topical ocular antihypertensive medications, with 73.5% of patients using no drops postoperatively compared to 55.3% in the control group.

Patients who started with three or more glaucoma medications saw a greater likelihood of sustained reduction in medication use, indicating that the iStent may help improve treatment adherence and reduce medication-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database. Wang, SY., Singh, K., Stein, JD., et al.[2020]

In an ex vivo whole human eye perfusion model, a single iStent reduced intraocular pressure (IOP) by 6.0 mmHg, and adding a second iStent further decreased IOP by 2.9 mmHg, totaling an 8.9 mmHg reduction, demonstrating its efficacy in lowering IOP.

Computational fluid dynamics modeling indicated that flow through the iStent devices is smooth and laminar, with negligible flow resistance, suggesting that these devices can effectively improve aqueous outflow and provide titratable options for achieving lower target IOPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. Hunter, KS., Fjield, T., Heitzmann, H., et al.[2022]

The iStent inject® device, used in a 74-year-old patient with glaucoma, successfully reduced intraocular pressure and medication use after cataract surgery, demonstrating its efficacy in managing glaucoma.

Using anterior segment optical coherence tomography (AS-OCT), the study revealed that the iStent inject® significantly dilated Schlemm's canal, suggesting that its pressure-lowering effect may involve both bypassing the trabecular meshwork and enhancing canal diameter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Segment Optical Coherence Tomography Signs of Local Dilatation Effect of a Micro-Stent on Schlemm's Canal. Gillmann, K., Bravetti, GE., Mansouri, K., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Glaukos iStent Trabecular Micro-Bypass. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Standalone iStent Trabecular Micro-bypass Glaucoma Surgery: A Systematic Review and Meta-Analysis. [2021]

5. Belgium pubmed.ncbi.nlm.nih.gov

The iStent trabecular micro-bypass stent: a case series. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

One-year analysis of the iStent trabecular microbypass in secondary glaucoma. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a Real-World Setting: A Longitudinal Retrospective Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Real-world Case Series of iStent or iStent inject Trabecular Micro-Bypass Stents Combined with Cataract Surgery. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. [2022]

11. Nepal pubmed.ncbi.nlm.nih.gov

Anterior Segment Optical Coherence Tomography Signs of Local Dilatation Effect of a Micro-Stent on Schlemm's Canal. [2019]