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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05411198

Enrollment

Registered

2022-06-09

Start date

2022-07-22

Completion date

2026-02-04

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma

Keywords

Open-Angle Glaucoma, Glaucoma, OAG, XEN45, Glaucoma Gel Stent, XEN45 Glaucoma Treatment System

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.

Interventions

DEVICEXEN45 (Glaucoma Gel Stent)

Ab externo implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Australia, United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026