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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the iStent Infinite, designed to help people with mild to moderate primary open-angle glaucoma. The goal is to determine if this tiny implant can effectively lower eye pressure when other treatments have failed. Good candidates for this trial are adults with primary open-angle glaucoma who have not succeeded with standard medical or surgical treatments. The trial focuses on those without other types of glaucoma or certain eye conditions, such as corneal inflammation. As an unphased trial, this study offers patients the chance to explore a new treatment option that may provide relief when other methods have not.

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 prior data suggests that the iStent Infinite device is safe for glaucoma patients?

Research has shown that the iStent Infinite device is very safe for patients. In a 12-month study, patients experienced very few problems or side effects during and after the procedure. The iStent Infinite is designed to help lower eye pressure, which is crucial for people with glaucoma.

Another study found that the device improves eye fluid drainage without causing major issues. This makes it a promising and safe treatment option for glaucoma. Overall, previous studies have shown that patients have tolerated the iStent Infinite well, suggesting it is a safe choice for managing eye pressure in glaucoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iStent Infinite device is unique because it offers a minimally invasive solution for managing glaucoma by directly targeting the eye's drainage system. Unlike traditional treatments like eye drops or laser therapy, which often focus on reducing eye pressure through medication or external procedures, the iStent Infinite is implanted inside the eye to bypass the trabecular meshwork. This approach could provide more consistent and long-term pressure reduction. Researchers are excited about this device because it has the potential to enhance fluid outflow in a more natural way, which may lead to better control of intraocular pressure and potentially reduce the need for additional medications.

What evidence suggests that the iStent Infinite device is effective for glaucoma?

Research has shown that the iStent Infinite device, which participants in this trial will receive, effectively lowers intraocular pressure, crucial for treating glaucoma. In one study, 82.7% of eyes with the iStent Infinite experienced at least a 20% reduction in eye pressure after six months. The device improves fluid drainage from the eye, reducing pressure. It is considered safe and offers a promising option for individuals with mild to moderate primary open-angle glaucoma. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006583/

The INTEGRITY Study - PMC - PubMed Central At month 6, a similar proportion of iStent infinite eyes (82.7%) versus Hydrus eyes (78.9%) achieved MDIOP reduction ≥ 20% from baseline ...

2. glaukos.com glaukos.com/glaucoma/products/istent-infinite/

iStent infinite® | Glaucoma Products The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03639870

Study Details | NCT03639870 | Investigation of the Glaukos ... Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three ...

4. glaukos.com glaukos.com/enca/glaucoma/istent-infinite-clinical-data/

Clinical Data for iStent infinite The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is ...

5. glaucomatoday.com glaucomatoday.com/resource/interventional-glaucoma-news-updates/articles/patient-success-stories-with-istent-infinite

Patient Success Stories With iStent Infinite The iStent infinite was selected due to its proven ability to enhance aqueous outflow and its favorable safety profile, making it an ideal choice for this ...

6. glaukos.com glaukos.com/glaucoma/istent-infinite-clinical-data/

iStent infinite® | Clinical Data In the 12-month pivotal trial, exceptional intraoperative and postoperative safety was demonstrated among patients with 2 or more failed filtering ...