Clinical trial NCT05411198: 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
Official title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Keywords: Open-Angle Glaucoma
Glaucoma
OAG
XEN45
Glaucoma Gel Stent
XEN45 Glaucoma Treatment System
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Glaucoma in the study eye.

  1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
  2. 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 Criteria:
* 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.

Primary outcomes:
measure: Percentage of Participants Achieving Effectiveness of XEN45
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision /ID# 245285
state: Arkansas
city: Pasadena
country: United States
facility: UCLA Doheny Eye Center /ID# 227587
state: California
city: Ventura
country: United States
facility: Ventura Ophthalmology /ID# 227585
state: California
city: Jacksonville
country: United States
facility: East Coast Institute for Research /ID# 255508
state: Florida
city: Sarasota
country: United States
facility: Center for Sight - Sarasota /ID# 227577
state: Florida
city: Vero Beach
country: United States
facility: New Vision Eye Center /ID# 261053
state: Florida
city: Atlanta
country: United States
facility: Georgia Eye Partners /ID# 245203
state: Georgia
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence /ID# 227576
state: Kansas
city: Bethesda
country: United States
facility: Johns Hopkins /ID# 245355
state: Maryland
city: Alexandria
country: United States
facility: Vance Thompson Vision /ID# 261125
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 245452
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center /ID# 227583
state: New York
city: Niagara Falls
country: United States
facility: Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 246840
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners, PC /ID# 245367
state: Pennsylvania
city: King Of Prussia
country: United States
facility: Kremer Eye Center - King of Prussia /ID# 245573
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision /ID# 260892
state: South Dakota
city: Dallas
country: United States
facility: Glaucoma Associates of Texas /ID# 227580
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 246848
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons, P.A. /ID# 227575
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 227572
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 245324
state: Utah
city: Falls Church
country: United States
facility: Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
state: Virginia
city: East Melbourne
country: Australia
facility: Eye Surgery Associates /ID# 252207
state: Victoria
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists /ID# 252353
state: Victoria
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: