iStent Infinite + iDose TR for Open-Angle Glaucoma

(POAG Trial)

Overseen By Jeanne L Molineaux, COA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jonathon Myers

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

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two treatments, iStent Infinite and iDose TR (a sustained-release implant), when used together for individuals with open-angle glaucoma unresponsive to regular treatments. Open-angle glaucoma causes high eye pressure, potentially leading to vision loss. The trial will assess whether these minimally invasive options can safely lower eye pressure as an alternative to more invasive surgeries. Suitable candidates have moderate to severe open-angle glaucoma and have not found success with other treatments or surgeries. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

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 is the safety track record for iStent Infinite and iDose TR?

Research has shown that both the iStent Infinite and iDose TR are safe to use. One study found that the iStent Infinite significantly lowered eye pressure in people with open-angle glaucoma, a common type of glaucoma, without any serious safety issues. Trials also showed that the iDose TR was well-received, delivering positive results without major side effects.

Previous studies have tested these treatments to ensure their safety and effectiveness. Both iStent Infinite and iDose TR offer less invasive options for lowering eye pressure, providing a safer alternative to more complex surgeries. Thorough testing has confirmed their safety for use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the iStent Infinite + iDose TR treatment because it offers a novel approach to managing open-angle glaucoma, especially in cases where medication alone isn't controlling the condition. Unlike traditional treatments that often rely on daily eye drops, this combination uses a minimally invasive surgical technique with the iStent Infinite to improve fluid drainage from the eye. Additionally, the iDose TR provides a sustained release of the medication travoprost directly within the eye, potentially reducing the need for frequent dosing and enhancing patient compliance. This dual-action approach not only targets the underlying pressure in the eye but also simplifies the treatment regimen for patients.

What evidence suggests that the iStent Infinite and iDose TR are effective for open-angle glaucoma?

Research has shown that using the iStent Infinite and iDose TR together effectively lowers eye pressure in people with open-angle glaucoma. The iDose TR, a tiny implant, releases travoprost directly into the eye to reduce pressure. Meanwhile, the iStent Infinite, a small device placed in the eye, improves fluid drainage, further lowering pressure. In one study, 82.7% of eyes treated with the iStent Infinite experienced a significant drop in eye pressure. These treatments are already approved for managing eye pressure and have proven effective for glaucoma. Participants in this trial will undergo surgery using the combined minimally invasive surgical iStent Infinite trabecular micro-bypass system model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg. ^{1 2 6 7 8}

Who Is on the Research Team?

Dilru Amarasekera, MD

Principal Investigator

Wills Eye Hospital Glaucoma Research

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe open-angle glaucoma, including those with pseudoexfoliation syndrome or cataracts. Participants should have glaucoma that isn't controlled by medication alone. Specific eligibility details are not provided, so it's best to contact the study team for more information.

Inclusion Criteria

Visual acuity HM or better

VF MD -6dB or worse

I have moderate to severe open angle glaucoma.

Exclusion Criteria

My glaucoma is caused by trauma, inflammation, new blood vessels, or blocked drainage in my eye.

I have had surgery for glaucoma before.

I have not had specific eye laser treatments in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgery using the combined minimally invasive iStent infinite and iDose TR

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including intraocular pressure reduction and medication changes

12 months

Regular visits (in-person) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• iDose TR
• iStent Infinite

Trial Overview The trial is testing a combination of two treatments: the iStent infinite (a device implanted in the eye) and iDose TR (a long-lasting drug implant), both designed to reduce pressure inside the eye without needing major surgery.

How Is the Trial Designed?

Group I: Surgery for patients with medically uncontrolled POAG Experimental Treatment 2 Interventions

surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg

Who Is Running the Clinical Trial?

Jonathon Myers

Lead Sponsor

Glaukos Corporation

Industry 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/

PMC Search Update - 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. clinicaltrials.gov clinicaltrials.gov/study/NCT07228221?aggFilters=status%3A%2Cphase%3A

Standalone iStent Infinite and iDose TR for Management of ... The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant ...

3. glaukos.com glaukos.com/glaucoma/

Glaucoma Treatment iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular ...

4. reviewofophthalmology.com reviewofophthalmology.com/article/a-medical-therapy-update

A Medical Therapy Update Travoprost intracameral implant for open-angle glaucoma or ocular hypertension: 12-month results of a randomized, double-masked trial.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/25158414241310275

Safety and efficacy of travoprost intracameral implant ... Travoprost intracameral implant for open-angle glaucoma or ocular hypertension: 12-month results of a randomized, double-masked trial.

6. 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.

7. healio.com healio.com/news/ophthalmology/20210113/glaukos-reports-positive-study-results-for-idose-tr-istent-infinite

Glaukos reports positive study results for iDose TR, iStent ... The iStent infinite demonstrated a substantial reduction in mean diurnal IOP in subjects with open-angle glaucoma in a 12-month investigational ...

8. link.springer.com link.springer.com/article/10.1007/s40123-024-00984-1

Ten-Year Effectiveness and Safety of Trabecular Micro- ... First-generation trabecular micro-bypass (iStent) implantation has been shown to be safe and effective over the short and long term, with ...