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

Open-Angle Glaucoma Clinical Trial

Official title:

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411198
• Other study ID #: 1924-703-007
• Status: Recruiting
• Phase: Phase 3
• Start date: July 22, 2022
• Est. completion date: August 15, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-Angle Glaucoma

Intervention

Device:
• XEN45 (Glaucoma Gel Stent)
Ab externo implant

Locations

Country	Name	City	State
Australia	Eye Surgery Associates /ID# 252207	East Melbourne	Victoria
Australia	Melbourne Eye Specialists /ID# 252353	Fitzroy	Victoria
United States	Vance Thompson Vision /ID# 261125	Alexandria	Minnesota
United States	Georgia Eye Partners /ID# 245203	Atlanta	Georgia
United States	Ophthalmic Partners, PC /ID# 245367	Bala-Cynwyd	Pennsylvania
United States	Johns Hopkins /ID# 245355	Bethesda	Maryland
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	Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925	Falls Church	Virginia
United States	Vold Vision /ID# 245285	Fayetteville	Arkansas
United States	East Coast Institute for Research /ID# 255508	Jacksonville	Florida
United States	Kremer Eye Center - King of Prussia /ID# 245573	King Of Prussia	Pennsylvania
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	Stiles Eyecare Excellence /ID# 227576	Overland Park	Kansas
United States	UCLA Doheny Eye Center /ID# 227587	Pasadena	California
United States	Washington University-School of Medicine /ID# 245452	Saint Louis	Missouri
United States	University of Utah /ID# 245324	Salt Lake City	Utah
United States	Eye associates /ID# 227572	San Antonio	Texas
United States	Center for Sight - Sarasota /ID# 227577	Sarasota	Florida
United States	Vance Thompson Vision /ID# 260892	Sioux Falls	South Dakota
United States	Ventura Ophthalmology /ID# 227585	Ventura	California
United States	New Vision Eye Center /ID# 261053	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Effectiveness of XEN45	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).	Month 12

External Links

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