iStent Infinite + iDose TR for Open-Angle Glaucoma
(POAG Trial)
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo surgery using the combined minimally invasive iStent infinite and iDose TR
Follow-up
Participants are monitored for safety and effectiveness after surgery, including intraocular pressure reduction and medication changes
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?
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Treatment groups
Experimental Treatment
surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonathon Myers
Lead Sponsor
Glaukos Corporation
Industry Sponsor
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
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 ...
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 ...
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 ...
A Medical Therapy Update
Travoprost intracameral implant for open-angle glaucoma or ocular hypertension: 12-month results of a randomized, double-masked trial.
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.
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.
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healio.com
healio.com/news/ophthalmology/20210113/glaukos-reports-positive-study-results-for-idose-tr-istent-infiniteGlaukos 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 ...
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 ...
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