iStent Infinite vs. Competitor Device for Glaucoma

Not currently recruiting at 1 trial location

Overseen By Khan Lau, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaukos Corporation

Disqualifiers: Traumatic glaucoma, Angle closure, 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: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two devices, the iStent Infinite and a competitor, to determine which better treats open-angle glaucoma. Open-angle glaucoma occurs when the eye's drainage canals become clogged over time, increasing eye pressure and potentially causing vision loss. The trial includes individuals diagnosed with primary open-angle glaucoma or certain secondary types, such as pseudoexfoliative or pigmentary glaucoma. It excludes those with other types, like traumatic or angle-closure glaucoma. Participants will receive one of the devices to evaluate which manages their condition more effectively. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future glaucoma treatments.

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 these devices are safe for treating glaucoma?

Research has shown that the iStent Infinite is safe for treating open-angle glaucoma. A 12-month study found the device to be very safe both during and after surgery. Patients experienced no major problems, even if previous surgeries had failed. This indicates that the iStent Infinite is generally well-tolerated.

Unfortunately, safety information for the competing device is unavailable. Therefore, it is important to consider all available information and consult healthcare providers before deciding to join this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The iStent Infinite is unique because it offers a minimally invasive approach to managing glaucoma. Unlike traditional methods that often involve eye drops or more invasive surgeries, the iStent Infinite is a tiny device implanted in the eye to help reduce pressure by improving fluid outflow. Researchers are excited about this treatment because it has the potential to provide long-term pressure reduction with a single procedure, reducing the need for daily medication and potentially improving patient adherence and quality of life.

What evidence suggests that this trial's treatments could be effective for open-angle glaucoma?

Research has shown that the iStent Infinite, one of the devices studied in this trial, effectively lowers eye pressure in people with open-angle glaucoma. In one study, about 82.7% of patients with the iStent Infinite experienced at least a 20% reduction in eye pressure from their initial levels. The device improves fluid flow out of the eye, reducing pressure. Patients have reported positive outcomes and a strong safety record. These findings suggest that the iStent Infinite could be a promising option for managing glaucoma. Meanwhile, this trial will also evaluate the effectiveness of a competitor device, providing a direct comparison between the two. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people with specific types of glaucoma: Primary Open-Angle Glaucoma, Secondary Pseudoexfoliative Glacoma, or Secondary Pigmentary Glaucoma. It's not suitable for those with other forms like traumatic, uveitic, neovascular glaucoma, angle closure glaucoma, and any linked to vascular disorders.

Inclusion Criteria

I have been diagnosed with a specific type of glaucoma.

Exclusion Criteria

I have a type of glaucoma other than open-angle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with either the iStent Infinite system or a competitor device

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Competitor Device
• iStent Infinite
• Ivantis Hydrus

Trial Overview The study compares the iStent Infinite device against a competitor's product in treating open-angle glaucoma. Participants will receive one of these devices to see which is more effective.

How Is the Trial Designed?

Group I: iStent Infinite Active Control 1 Intervention

Subjects implanted with iStent Infinite system

Group II: Competitor Device Active Control 1 Intervention

Subject implanted with competitor device

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

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/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 ...

3. 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.

4. 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 ...

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 ...