Travoprost Implant + iStent vs. iStent Alone for Glaucoma
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
12456How 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.
12478Eligibility 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
+2 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: iDose TRExperimental Treatment2 Interventions
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
Group II: sham procedurePlacebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Glaukos Clinical Study SiteColorado Springs, CO
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Who Is Running the Clinical Trial?
Glaukos CorporationLead Sponsor
References
Effectiveness and Safety of iStent Infinite Trabecular Micro-Bypass for Uncontrolled Glaucoma. [2023]The iStent Infinite Trabecular Micro-Bypass System implanted in patients with open angle glaucoma (OAG) (uncontrolled by prior surgical or medical therapy) was effective in reducing mean diurnal intraocular pressure with a favorable safety profile.
Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma. [2023]This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG).
The iStent trabecular micro-bypass stent: a case series. [2022]To evaluate the safety and effectiveness of a trabecular micro-bypass stent, the iStent (Glaukos, USA), for reduction of intraocular pressure in patients with open angle glaucoma.
Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. [2022]The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject (®) trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol.
One-Year Comparative Evaluation of iStent or iStent inject Implantation Combined with Cataract Surgery in a Single Center. [2023]Label="INTRODUCTION">This retrospective consecutive case series assessed 12-month effectiveness and safety of iStent® or iStent inject® trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.
iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control. [2022]Label="INTRODUCTION">This study evaluated the 5-year effectiveness and safety of iStent inject® trabecular micro-bypass with or without cataract surgery (Combined or Standalone, respectively) in patients with open-angle glaucoma (OAG).
iStent inject: comprehensive review. [2021]Microinvasive glaucoma surgeries (MIGSs) are new surgical procedures for treatment of glaucoma. They aim to safely and effectively reduce intraocular pressure (IOP) with minimal trauma to the eye and less complications. The first-generation iStent is the first approved ab interno MIGS implant for management of open-angle glaucoma. It works by allowing aqueous humor to drain directly from the anterior chamber into Schlemm canal bypassing the trabecular meshwork, the major site of outflow resistance. The second-generation iStent inject is the smallest available trabecular device that occupies less than 0.5 mm. It is designed to facilitate the surgical technique and allow simultaneous implantation of 2 stents, aiming for more IOP reduction. This review examines publications about the iStent inject, focusing on the device's efficacy, safety, and comparison with the first generation iStent. Both devices were found to be a safe and effective tool in management of open-angle glaucoma.
Characterization of micro-invasive trabecular bypass stents by ex vivo perfusion and computational flow modeling. [2022]Micro-invasive glaucoma surgery with the Glaukos iStent® or iStent inject® (Glaukos Corporation, Laguna Hills, CA, USA) is intended to create a bypass through the trabecular meshwork to Schlemm's canal to improve aqueous outflow through the natural physiologic pathway. While the iStent devices have been evaluated in ex vivo anterior segment models, they have not previously been evaluated in whole eye perfusion models nor characterized by computational fluid dynamics. Intraocular pressure (IOP) reduction with the iStent was evaluated in an ex vivo whole human eye perfusion model. Numerical modeling, including computational fluid dynamics, was used to evaluate the flow through the stents over physiologically relevant boundary conditions. In the ex vivo model, a single iStent reduced IOP by 6.0 mmHg from baseline, and addition of a second iStent further lowered IOP by 2.9 mmHg, for a total IOP reduction of 8.9 mmHg. Computational modeling showed that simulated flow through the iStent or iStent inject is smooth and laminar at physiological flow rates. Each stent was computed to have a negligible flow resistance consistent with an expected significant decrease in IOP. The present perfusion results agree with prior clinical and laboratory studies to show that both iStent and iStent inject therapies are potentially titratable, providing clinicians with the opportunity to achieve lower target IOPs by implanting additional stents.