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
- Conditions
- Open-Angle Glaucoma
- Interventions
- Device: XEN45 (Glaucoma Gel Stent)
- Registration Number
- NCT05411198
- Lead Sponsor
- AbbVie
- 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 approach. Adverse events and intraocular pressure will be assessed.
XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States.
All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months.
Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
-
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.
-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XEN45 (Glaucoma Gel Stent) XEN45 (Glaucoma Gel Stent) Participants will receive XEN45 implanted using an ab externo approach on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Effectiveness of XEN45 Month 12 Effectiveness is defined as achieving 20% or more reduction of intraocular pressure (IOP) from baseline and on the same or fewer number of glaucoma medications than at baseline without secondary surgical intervention for IOP (SSII).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Vold Vision /ID# 245285
🇺🇸Fayetteville, Arkansas, United States
UCLA Doheny Eye Center /ID# 227587
🇺🇸Pasadena, California, United States
Ventura Ophthalmology /ID# 227585
🇺🇸Ventura, California, United States
East Coast Institute for Research /ID# 255508
🇺🇸Jacksonville, Florida, United States
Center for Sight - Sarasota /ID# 227577
🇺🇸Sarasota, Florida, United States
New Vision Eye Center /ID# 261053
🇺🇸Vero Beach, Florida, United States
Georgia Eye Partners /ID# 245203
🇺🇸Atlanta, Georgia, United States
Stiles Eyecare Excellence /ID# 227576
🇺🇸Overland Park, Kansas, United States
Johns Hopkins /ID# 245355
🇺🇸Bethesda, Maryland, United States
Vance Thompson Vision /ID# 261125
🇺🇸Alexandria, Minnesota, United States
Washington University-School of Medicine /ID# 245452
🇺🇸Saint Louis, Missouri, United States
NYU Langone Medical Center /ID# 227583
🇺🇸New York, New York, United States
Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165
🇺🇸Niagara Falls, New York, United States
Oklahoma Eye Surgeons /ID# 246840
🇺🇸Oklahoma City, Oklahoma, United States
Ophthalmic Partners, PC /ID# 245367
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Kremer Eye Center - King of Prussia /ID# 245573
🇺🇸King Of Prussia, Pennsylvania, United States
Vance Thompson Vision /ID# 260892
🇺🇸Sioux Falls, South Dakota, United States
Glaucoma Associates of Texas /ID# 227580
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center /ID# 246848
🇺🇸Dallas, Texas, United States
El Paso Eye Surgeons, P.A. /ID# 227575
🇺🇸El Paso, Texas, United States
Eye associates /ID# 227572
🇺🇸San Antonio, Texas, United States
University of Utah /ID# 245324
🇺🇸Salt Lake City, Utah, United States
Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
🇺🇸Falls Church, Virginia, United States
Eye Surgery Associates /ID# 252207
🇦🇺East Melbourne, Victoria, Australia
Melbourne Eye Specialists /ID# 252353
🇦🇺Fitzroy, Victoria, Australia