Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma

NCT07228221 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: WEH IRB #2025-51
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.

Conditions

Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma

Keywords

POAG; PG; PXG

Outcome Measures

Primary Outcomes (1)

• IOP reduction from baseline

  a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.

  Diurnal IOP reduction from baseline at 12 months

Study Arms (1)

Surgery for patients with medically uncontrolled POAG

EXPERIMENTAL

surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg

Device: iStent infinite trabecular micro-bypass system model iS3; Drug: iDose TR (Travoprost intracameral Implant) 75mcg

Interventions

iStent infinite trabecular micro-bypass system model iS3 DEVICE

surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3

Surgery for patients with medically uncontrolled POAG

iDose TR (Travoprost intracameral Implant) 75mcg DRUG

surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg

Surgery for patients with medically uncontrolled POAG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonathon Myers: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Wills Eye Hosital Glaucoma Dept.

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Dilru Amarasekera, MD

  Wills Eye Hospital Glaucoma Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meskerem Divers

CONTACT

215-825-4712; mdivers@willseye.org

Jeanne L Molineaux, COA

CONTACT

215-825-4713; jmolineaux@willseye.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Model Details: Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): August 30, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: This is a 5 year study with anticipated completion of enrollment and data December 2031.
• Access Criteria: Researchers can request the study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data with a description of their planned use

Locations

US (1)