Completed
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent
Led by AbbVie · Updated on 2026-02-27
74
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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.
-
You will not qualify if you...
- 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.
Trial Site Locations
Total: 25 locations
1
Vold Vision /ID# 245285
Fayetteville, Arkansas, United States, 72704
Status Unknown
2
UCLA Doheny Eye Center /ID# 227587
Pasadena, California, United States, 91105
Status Unknown
3
Ventura Ophthalmology /ID# 227585
Ventura, California, United States, 93003
Status Unknown
4
East Coast Institute for Research /ID# 255508
Jacksonville, Florida, United States, 32256-9680
Status Unknown
5
Center for Sight - Sarasota /ID# 227577
Sarasota, Florida, United States, 34239
Status Unknown
6
New Vision Eye Center /ID# 261053
Vero Beach, Florida, United States, 32960-6551
Status Unknown
7
Georgia Eye Partners /ID# 245203
Atlanta, Georgia, United States, 30342
Status Unknown
8
Stiles Eyecare Excellence /ID# 227576
Overland Park, Kansas, United States, 66213
Status Unknown
9
The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355
Bethesda, Maryland, United States, 20817
Status Unknown
10
Vance Thompson Vision /ID# 261125
Alexandria, Minnesota, United States, 56308-3408
Status Unknown
11
Washington University-School of Medicine /ID# 245452
St Louis, Missouri, United States, 63110
Status Unknown
12
NYU Langone Medical Center /ID# 227583
New York, New York, United States, 10016-6402
Status Unknown
13
Fichte Endl & Elmer Eyecare /ID# 245165
Niagara Falls, New York, United States, 14304
Status Unknown
14
Oklahoma Eye Surgeons /ID# 246840
Oklahoma City, Oklahoma, United States, 73112
Status Unknown
15
Ophthalmic Partners, PC /ID# 245367
Bala-Cynwyd, Pennsylvania, United States, 19004
Status Unknown
16
Kremer Eye Center - King of Prussia /ID# 245573
King of Prussia, Pennsylvania, United States, 19406
Status Unknown
17
Vance Thompson Vision /ID# 260892
Sioux Falls, South Dakota, United States, 57108
Status Unknown
18
Glaucoma Associates of Texas /ID# 227580
Dallas, Texas, United States, 75231
Status Unknown
19
University of Texas Southwestern Medical Center /ID# 246848
Dallas, Texas, United States, 75390-7208
Status Unknown
20
El Paso Eye Surgeons, P.A. /ID# 227575
El Paso, Texas, United States, 79902
Status Unknown
21
Eye associates /ID# 227572
San Antonio, Texas, United States, 78229
Status Unknown
22
University of Utah /ID# 245324
Salt Lake City, Utah, United States, 84112-5500
Status Unknown
23
Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
Falls Church, Virginia, United States, 22042-3013
Status Unknown
24
Eye Surgery Associates /ID# 252207
East Melbourne, Victoria, Australia, 3002
Status Unknown
25
Melbourne Eye Specialists /ID# 252353
Fitzroy, Victoria, Australia, VIC3065
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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