← Back to Search

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).
Must not have
A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area
Excessive intraoperative bleeding, such that visualization in the study eye is impaired
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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
Select...
I have been diagnosed with neovascular glaucoma.
Select...
I have a condition that makes standard glaucoma surgery likely to fail.
Select...
My glaucoma is not controlled by medication.
Select...
I have glaucoma in one of my eyes.
Select...
I have had one or more unsuccessful glaucoma surgeries.
Select...
I have undergone and not responded to treatments like cryotherapy for my eye condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My eye's outer layer is healthy and moves freely, with no scars or past surgeries.
Select...
I experienced heavy bleeding in my eye during surgery, affecting my vision.
Select...
My eye's structure makes it hard for doctors to see inside it clearly.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Effectiveness of XEN45

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,029 Previous Clinical Trials
521,465 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,951 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
~14 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top