iStent infinite plus iDose TR for moderate-to-severe open-angle glaucoma

iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)

This trial will see if placing an iStent infinite device together with an iDose TR travoprost implant can lower eye pressure and reduce glaucoma eye drops for people with moderate to severe open-angle glaucoma not controlled by medication or laser.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wills Eye (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07228221 on ClinicalTrials.gov

What this trial studies

This Phase 4, interventional study enrolls patients with moderate to severe open-angle glaucoma who have failed medical and/or laser therapy and for whom incisional surgery is being considered. Participants will undergo standalone implantation of the iStent infinite trabecular micro-bypass system and the iDose TR intracameral travoprost implant. Investigators will measure mean intraocular pressure change from baseline, change in number of glaucoma medications, the proportion needing additional incisional glaucoma surgery, and the incidence of adverse events over the study period. The hypothesis is that the combined minimally invasive device plus drug depot will produce a safe and meaningful reduction in intraocular pressure and medication burden compared with baseline.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate-to-severe open-angle glaucoma (including POAG, pigmentary, or pseudoexfoliation glaucoma), open angles (Shaffer grade ≥3), visual acuity of hand motions or better, visual field mean deviation ≤ -6 dB, who have failed topical or laser therapy and are considering incisional surgery.

Not a fit: Patients with angle-closure, uveitic, neovascular or traumatic glaucoma, prior incisional glaucoma surgery, active ocular inflammation, clinically significant corneal disease, recent laser within 90 days, or corneal pathology preventing accurate applanation tonometry are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the combined device-and-drug approach could lower intraocular pressure, reduce or eliminate daily glaucoma medications, and decrease the need for more invasive filtering surgery.

How similar studies have performed: Previous studies of trabecular micro-bypass stents and of intracameral travoprost implants have shown intraocular pressure and medication reductions, but combining the standalone iStent infinite and iDose TR as a single procedure is a relatively new approach with limited published data.

Eligibility criteria

Inclusion Criteria:

* Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
* Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
* Visual acuity HM or better
* VF MD -6dB or worse
* Failed medical therapy and/or laser treatment
* Incisional glaucoma surgery contemplated as next intervention
* Phakic or pseudophakic

Exclusion Criteria:

* Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
* Previous incisional glaucoma surgery
* ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
* Active ocular inflammation or edema, clinically significant corneal dystrophy
* Corneal or other pathology preventing accurate Goldmann applanation tonometry

Where this trial is running

Philadelphia, Pennsylvania

• Wills Eye Hosital Glaucoma Dept. — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Dilru Amarasekera, MD — Wills Eye Hospital Glaucoma Research
• Study coordinator: Meskerem Divers

Conditions: Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma, POAG, PG, PXG