A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

Phase 3

Recruiting

• Conditions: Primary Open Angle Glaucoma

• Registration Number: NCT06822738
• Lead Sponsor: AbbVie

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 interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed.

XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in select countries in North America and Europe.

Participants will receive XEN63 implanted using either the ab interno approach or 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

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study Start: 2025-02-11
• Study First Posted: 2025-02-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)

  1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt)
  2. Uncontrolled by medical therapy (to meet out-of-US [OUS] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort.

Exclusion Criteria

• History of angle-closure glaucoma where the angle has not been surgically opened in the SE.
• History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE.
• Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Response of Achieving ≥ 20% Reduction in Intraocular Pressure (IOP) From Baseline on the Same or Fewer Number of IOP-Lowering Medications Compared to Baseline	Month 12	IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.
Number of Participants with Adverse Events (AEs)	Month 12	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Mean Diurnal IOP	Month 12	IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye at Month 12.
Change From Baseline in Diurnal IOP	Baseline to Month 12	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change from Baseline in Number of Topical IOP-Lowering Medications	Baseline to Month 12	A numerical count by class of drug of topical IOP lowering medications being taken.
Mean Number of Topical IOP-Lowering Medications	Month 12	A numerical count by class of drug of topical IOP lowering medications being taken.

Trial Locations

Locations (11)

Wills Eye Hospital Glaucoma Dept /ID# 268569; 🇺🇸 Philadelphia, Pennsylvania, United States

Arizona Advanced Eye Research Institute /ID# 268363; 🇺🇸 Glendale, Arizona, United States

LA Glaucoma Group /ID# 268444; 🇺🇸 Culver City, California, United States

New Vision Eye Center /ID# 269955; 🇺🇸 Vero Beach, Florida, United States

Coastal Research Associates - Roswell /ID# 268458; 🇺🇸 Roswell, Georgia, United States

Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451; 🇺🇸 Overland Park, Kansas, United States

Minnesota Eye Consultants - Minneapolis /ID# 272445; 🇺🇸 Minneapolis, Minnesota, United States

Vance Thompson Vision - Omaha /ID# 271599; 🇺🇸 Omaha, Nebraska, United States

Oklahoma Eye Surgeons /ID# 269174; 🇺🇸 Oklahoma City, Oklahoma, United States

Glaucoma Associates Of Texas /ID# 268745; 🇺🇸 Dallas, Texas, United States

El Paso Eye Surgeons /ID# 268356; 🇺🇸 El Paso, Texas, United States