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Device

XEN45 Gel Stent for Open-Angle Glaucoma

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have neovascular glaucoma
Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Study Summary

This trial will help assess the safety and effectiveness of a glaucoma gel stent when implanted using the ab externo approach.

Who is the study for?
This trial is for people aged 45 or older with open-angle glaucoma who've had unsuccessful previous glaucoma surgeries, such as filtering surgery or tube shunt. It's also for those with conditions like conjunctival scarring or uveitis where standard surgery might fail. Participants should not have eye anatomy that limits the view of certain areas, excessive bleeding during operation, scarred conjunctiva in the target area, or other complications affecting stent placement.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a XEN45 Glaucoma Gel Stent implanted using an ab externo approach (outside the eye). All participants will receive this treatment on Day 1 and be monitored over 12 months through regular hospital visits to assess changes in intraocular pressure and overall impact on their glaucoma condition.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks associated with similar procedures may include discomfort at the implant site, infection risk, potential vision changes or loss if complications occur. Regular medical assessments aim to monitor these adverse events throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with neovascular glaucoma.
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I have a condition that makes standard glaucoma surgery likely to fail.
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My glaucoma is not controlled by medication.
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I have glaucoma in one of my eyes.
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I have had one or more unsuccessful glaucoma surgeries.
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I have undergone and not responded to treatments like cryotherapy for my eye condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Effectiveness of XEN45

Trial Design

1Treatment groups
Experimental Treatment
Group I: XEN45 (Glaucoma Gel Stent)Experimental Treatment1 Intervention
Participants will receive XEN45 implanted using an ab externo approach on Day 1.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,330 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,044 Total Patients Enrolled

Media Library

XEN45 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05411198 — Phase 3
Open-Angle Glaucoma Patient Testimony for trial: Trial Name: NCT05411198 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in this experiment?

"Sixty-five volunteers are needed for this study, all of whom must meet the prerequisites specified in the inclusion criteria. Some locations where patients can participate in this trial include Washington University-School of Medicine /ID# 245452 in Saint Louis, Missouri and Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925 in Falls Church, Virginia."

Answered by AI

Is this test being performed in numerous hospitals across America?

"This trial is accepting patients at Washington University-School of Medicine /ID# 245452 in Saint Louis, Missouri, Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925 in Falls Church, Virginia, and Oklahoma Eye Surgeons /ID# 246840 in Oklahoma City, Oklahoma. There are also 24 other locations that are participating."

Answered by AI

Are patients still being recruited for this research project?

"The study is currently looking for participants, with the first posting on clinicaltrials.gov being on 7/22/2022 and most recent update happening on 10/24/2022."

Answered by AI

Does XEN45 (Glaucoma Gel Stent) have any permanent side effects?

"There is prior clinical data supporting the safety of XEN45, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Massachusetts
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
UCLA Doheny Eye Center /ID# 227587
Ophthalmic Consultants of Connecticut - Fairfield /ID# 246798
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

How long do the screening visits take?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have two of the topical I'm medications that are only partially effective on reducing the intraocular pressure.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma
2022. "Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05411198.
All > Glaucoma Long Beach > Glaucoma
~27 spots leftby Aug 2025
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