Travoprost Implant + iStent vs. iStent Alone for Glaucoma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Glaukos Corporation

Disqualifiers: Hypersensitivity to travoprost, Visual acuity worse than 20/80, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial involves adults with high eye pressure who have an iStent. They will receive either a travoprost implant, which releases medication to lower eye pressure, or a non-medicated procedure. The study will follow them for about a year.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to understand any specific requirements.

What data supports the effectiveness of the treatment iStent Infinite, iStent infinite, iStent infinite Trabecular Micro-Bypass System Model iS3, Travoprost Intraocular Implant, iDose TR, Travoprost for glaucoma?

Research shows that the iStent Infinite Trabecular Micro-Bypass System is effective in lowering eye pressure in patients with open-angle glaucoma, especially when other treatments haven't worked. This suggests it could be a helpful part of the treatment for glaucoma. ^{1 2 3 4 5}

Is the iStent Infinite safe for use in humans?

The iStent Infinite has been shown to have a favorable safety profile in patients with open-angle glaucoma, meaning it is generally safe for use in humans. ^{1 2 4 5 6}

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

The iStent Infinite treatment is unique because it involves a micro-bypass system that helps reduce eye pressure by creating a direct drainage path for fluid in the eye, which is less invasive and has fewer complications compared to traditional surgeries. It is particularly effective for patients whose glaucoma is not controlled by other surgical or medical therapies. ^{1 2 4 7 8}

Research Team

Study Director

Principal Investigator

Glaukos Corporation

Eligibility Criteria

This trial is for adults with open-angle glaucoma or ocular hypertension who have had the iStent infinite system placed in their eye. They must not have an unmedicated eye pressure over 36 mmHg, be allergic to travoprost, have a high cup/disc ratio, poor vision worse than 20/80, or any other risky eye conditions.

Inclusion Criteria

I have been diagnosed with open-angle glaucoma or high eye pressure.

Your intraocular pressure in the study eye meets the requirements for participation.

Exclusion Criteria

I do not have any eye conditions that could risk my health in the study.

My eye pressure is over 36 mmHg without medication.

Vertical cup/disc ratio > 0.8 in the study eye

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a travoprost intraocular implant or a sham procedure after successful iStent infinite placement

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• iStent Infinite (Device)
• Travoprost Intraocular Implant (Prostaglandin Analog)

Trial Overview The study tests if adding a travoprost intraocular implant after placing the iStent infinite device helps lower eye pressure better than the stent alone. Participants are randomly chosen to get either the real implant or a pretend procedure and will be monitored for one year.

Participant Groups

Group I: iDose TR Experimental Treatment 2 Interventions

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Group II: sham procedure Placebo Group 2 Interventions

Sham surgical procedure in subjects who had successful iStent infinite placement

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 of 40 patients with primary open-angle glaucoma, both the iStent inject and Hydrus Microstent effectively reduced intraocular pressure (IOP) and the need for glaucoma medications after 12 months, showing similar outcomes overall.

However, the iStent inject group experienced no adverse events, while the Hydrus group had device-related complications that required additional surgeries, indicating a safety advantage for the iStent inject.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma. Shultz, M., Chorbajian, A., Zohouralen, A.[2023]

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 192 subjects with open-angle glaucoma, implantation of two iStent inject devices resulted in a statistically significant greater reduction in intraocular pressure (IOP) compared to medical therapy, with 94.7% of the stent group achieving a ≥20% IOP reduction versus baseline.

Both treatment options demonstrated a high safety profile, with stable visual acuity and minimal adverse events, indicating that iStent inject not only matches the efficacy of medication but also reduces the burden of daily medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Fea, AM., Belda, JI., Rękas, M., et al.[2022]

In a study of 58 eyes with open-angle glaucoma undergoing cataract surgery, the iStent inject showed significantly greater reductions in intraocular pressure (IOP) compared to the iStent, with mean IOP dropping to 13.1 mmHg versus 15.4 mmHg after 12 months.

Both iStent and iStent inject led to substantial reductions in glaucoma medication use, but the iStent inject group had a higher percentage of patients completely off medications (95.7% vs. 71.4%), indicating its superior efficacy in managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Comparative Evaluation of iStent or iStent inject Implantation Combined with Cataract Surgery in a Single Center. Guedes, RAP., Gravina, DM., Lake, JC., et al.[2023]

The iStent inject® procedure significantly reduced intraocular pressure (IOP) by nearly 10 mmHg and decreased the need for glaucoma medications by about 2 medications over a 5-year period in 125 patients with open-angle glaucoma, demonstrating its long-term effectiveness.

The procedure was safe, with no intraoperative complications reported and stable disease indicators throughout the follow-up, indicating that both Combined and Standalone approaches yielded similar positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control. Hengerer, FH., Auffarth, GU., Conrad-Hengerer, I.[2022]

The second-generation iStent inject is a microinvasive glaucoma surgery device that allows for the implantation of two stents simultaneously, potentially leading to greater reductions in intraocular pressure (IOP) compared to the first-generation iStent.

Both the iStent and iStent inject have been shown to be safe and effective for managing open-angle glaucoma, with minimal trauma and complications, making them promising options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iStent inject: comprehensive review. Shalaby, WS., Jia, J., Katz, LJ., et al.[2021]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma. [2023]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

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

Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. [2022]

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

One-Year Comparative Evaluation of iStent or iStent inject Implantation Combined with Cataract Surgery in a Single Center. [2023]

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

iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control. [2022]

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

iStent inject: comprehensive review. [2021]

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

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