Travoprost Implant + iStent vs. iStent Alone for Glaucoma

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Glaukos Corporation

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

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with glaucoma or high eye pressure. Participants will receive either a travoprost implant (Travoprost Intraocular Implant), which releases medication directly into the eye, or a sham procedure to compare effectiveness. The trial aims to determine if the implant lowers eye pressure more effectively than the iStent alone. It targets those who have already had the iStent placed and still experience high eye pressure. Suitable candidates include those with open-angle glaucoma or high eye pressure, excluding individuals with very poor vision or allergies to the medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the travoprost eye implant is generally well-tolerated. Earlier studies identified some common side effects as mild, such as eye inflammation, occurring in 0.5% to 5.1% of patients, and eye redness, seen in about 2.6% to 3.0% of patients. Some patients also experienced a decrease in vision sharpness.

These findings suggest that while the treatment is mostly safe, it can have side effects like any medical procedure. However, these are usually not serious. The implant's approval for use in other conditions supports its safety. It is important to discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about the Travoprost Intraocular Implant (iDose TR) because it offers a new way to deliver medication directly to the eye in patients with glaucoma. Unlike traditional treatments that require daily eye drops, this implant provides a sustained release of the medication travoprost, potentially improving adherence and consistency in treatment. Additionally, the iStent Infinite device, when used in combination with the implant, aims to enhance fluid drainage from the eye, further reducing intraocular pressure. This dual approach could significantly improve treatment outcomes for glaucoma patients compared to current methods.

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

In this trial, participants will receive either the Travoprost intraocular implant, known as iDose TR, or undergo a sham procedure. Research has shown that the Travoprost intraocular implant effectively lowers eye pressure in people with glaucoma. Specifically, studies found that the implant can significantly reduce eye pressure for at least three months after just one treatment. Impressively, about 70% of patients maintained well-controlled eye pressure even three years later, often needing fewer eye drops. This treatment works by slowly releasing Travoprost, a medication that helps fluid drain from the eye, reducing pressure and preventing damage. These promising results suggest that the Travoprost implant could be a helpful treatment option for managing glaucoma. ^{1 4 5 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• iStent Infinite
• Travoprost Intraocular Implant

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.

How Is the Trial Designed?

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

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

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 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 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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38423216/

Phase 3 Randomized Clinical Trial of the Safety and ... The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration.

2. glaucomatoday.com glaucomatoday.com/articles/2024-nov-dec-insert2/a-deep-dive-on-the-idosesupsup-tr-phase-2b-trial

A Deep Dive on the iDose® TR Phase 2b Trial iDose TR demonstrated 1.3 mm Hg statistically superior IOP-lowering versus pretrial PGAs,1 making it a “meaningful addition to the interventional glaucoma ...

3. idosetrhcp.com idosetrhcp.com/efficacy/

Efficacy of iDose® TR (travoprost intracameral implant) The primary endpoint was the change in diurnal IOP (vs timolol) through 3 months post implantation. Patients aged ≥18 years with OAG (POAG, PXG, or PG) or OHT, ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/218010Orig1s000MedR.pdf

218010Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov iDose TR (travoprost intraocular implant) is a sterile intraocular implant containing 75 µg of travoprost, a prostaglandin analog, with.

5. renoeyecare.com renoeyecare.com/blog/glaucoma/positive-outcomes-for-phase-3-trials-idose-tr/

Positive Outcomes for Phase 3 Trials of iDose TR Approximately 70% of iDose TR subjects maintained well-controlled IOP on the same or fewer topical medications three years after a single ...

6. glaukos.com glaukos.com/wp-content/uploads/2025/01/Berdahl-et-al-2023.pdf

Efficacy and Safety of the Travoprost Intraocular Implant in ... Conclusion The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP- lowering medication burden ...

7. aaojournal.org aaojournal.org/article/S0161-6420(24)00161-1/fulltext

Phase 3 Randomized Clinical Trial of the Safety and ... The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual ...