Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Open-Angle Glaucoma
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo ...
Eligibility Criteria
Inclusion
- Glaucoma in the study eye.
- Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
- Study eye that meet at least one of the following criteria:
- Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
- Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
- 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).
- Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.
Exclusion
- 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.
- Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
- Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05411198
Start Date
July 22 2022
End Date
February 4 2026
Last Update
February 27 2026
Active Locations (25)
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1
Vold Vision /ID# 245285
Fayetteville, Arkansas, United States, 72704
2
UCLA Doheny Eye Center /ID# 227587
Pasadena, California, United States, 91105
3
Ventura Ophthalmology /ID# 227585
Ventura, California, United States, 93003
4
East Coast Institute for Research /ID# 255508
Jacksonville, Florida, United States, 32256-9680