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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05411198

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 0 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.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma	Device: XEN45 (Glaucoma Gel Stent)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 14, 2022

Anticipated Primary Completion Date :

Mar 13, 2025

Anticipated Study Completion Date :

Mar 13, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XEN45 (Glaucoma Gel Stent) Participants will receive XEN45 implanted using an ab externo approach on Day 0.	Device: XEN45 (Glaucoma Gel Stent) Ab externo implant

Arm

Intervention/Treatment

Experimental: XEN45 (Glaucoma Gel Stent)

Participants will receive XEN45 implanted using an ab externo approach on Day 0.

Device: XEN45 (Glaucoma Gel Stent)

Ab externo implant

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eyes diagnosed with open-angle glaucoma uncontrolled by medical therapy that meet at least one of the following criteria (additionally, a maximum of 15 participants that do not meet the criteria below can be enrolled):
Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 20 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).

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Ophthalmic Consultants of Connecticut - Fairfield /ID# 246798	Fairfield	Connecticut	United States	06824-5318
5	Center for Sight - Sarasota /ID# 227577	Sarasota	Florida	United States	34239
6	Georgia Eye Partners /ID# 245203	Atlanta	Georgia	United States	30342
7	Stiles Eyecare Excellence /ID# 227576	Overland Park	Kansas	United States	66213
8	Johns Hopkins /ID# 245355	Bethesda	Maryland	United States	20817
9	Ophthalmic Consultants of Boston /ID# 227573	Boston	Massachusetts	United States	02129
10	University of Michigan, Kellogg Eye Center /ID# 227586	Ann Arbor	Michigan	United States	48105
11	New York University, Langone Health /ID# 227583	New York	New York	United States	10017
12	Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165	Niagara Falls	New York	United States	14304
13	Oklahoma Eye Surgeons /ID# 246840	Oklahoma City	Oklahoma	United States	73112
14	Ophthalmic Partners, PC /ID# 245367	Bala-Cynwyd	Pennsylvania	United States	19004
15	Kremer Eye Center - King of Prussia /ID# 245573	King Of Prussia	Pennsylvania	United States	19406
16	University of Tennessee Health Science Center /ID# 245449	Memphis	Tennessee	United States	38103-3403
17	Glaucoma Associates of Texas /ID# 227580	Dallas	Texas	United States	75231
18	University of Texas Southwestern Medical Center /ID# 246848	Dallas	Texas	United States	75390-7208
19	El Paso Eye Surgeons, P.A. /ID# 227575	El Paso	Texas	United States	79902
20	Eye associates /ID# 227572	San Antonio	Texas	United States	78229
21	University of Utah /ID# 245324	Salt Lake City	Utah	United States	84112-5500