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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).
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
Pivotal Trial
No Placebo-Only Group
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 belowSelect...
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,040 Previous Clinical Trials
523,514 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,299 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Open-Angle Glaucoma Patient Testimony for trial: Trial Name: NCT05411198 — Phase 3