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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Open-Angle Glaucoma

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XEN45 (Glaucoma Gel Stent)

Participants will receive XEN45 implanted using an ab externo approach on Day 1.

Group Type EXPERIMENTAL

XEN45 (Glaucoma Gel Stent)

Intervention Type DEVICE

Ab externo implant

Interventions

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XEN45 (Glaucoma Gel Stent)

Ab externo implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Facility Contacts

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Site Coordinator

Role: primary

Site Coordinator

Role: primary

Other Identifiers

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1924-703-007

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

XEN45 (Glaucoma Gel Stent)

XEN45 (Glaucoma Gel Stent)

Interventions

XEN45 (Glaucoma Gel Stent)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AbbVie

Responsible Party

Principal Investigators

ABBVIE INC.

Locations

Vold Vision /ID# 245285

UCLA Doheny Eye Center /ID# 227587

Ventura Ophthalmology /ID# 227585

East Coast Institute for Research /ID# 255508

Center for Sight - Sarasota /ID# 227577

New Vision Eye Center /ID# 261053

Georgia Eye Partners /ID# 245203

Stiles Eyecare Excellence /ID# 227576

The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355

Vance Thompson Vision /ID# 261125

Washington University-School of Medicine /ID# 245452

NYU Langone Medical Center /ID# 227583

Fichte Endl & Elmer Eyecare /ID# 245165

Oklahoma Eye Surgeons /ID# 246840

Ophthalmic Partners, PC /ID# 245367

Kremer Eye Center - King of Prussia /ID# 245573

Vance Thompson Vision /ID# 260892

Glaucoma Associates of Texas /ID# 227580

University of Texas Southwestern Medical Center /ID# 246848

El Paso Eye Surgeons, P.A. /ID# 227575

Eye associates /ID# 227572

University of Utah /ID# 245324

Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925

Eye Surgery Associates /ID# 252207

Melbourne Eye Specialists /ID# 252353

Countries

Central Contacts

ABBVIE CALL CENTER

Facility Contacts

Site Coordinator

Site Coordinator

Related Links

Other Identifiers

1924-703-007