Clinical trial NCT06822738: 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
Official title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Keywords: Primary Open Angle Glaucoma
AGN-9003
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 130
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Month 12
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Month 12
Secondary outcomes:
measure: Mean Diurnal IOP
timeFrame: Month 12
measure: Change From Baseline in Diurnal IOP
timeFrame: Baseline to Month 12
measure: Change from Baseline in Number of Topical IOP-Lowering Medications
timeFrame: Baseline to Month 12
measure: Mean Number of Topical IOP-Lowering Medications
timeFrame: Month 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute /ID# 268363
state: Arizona
city: Culver City
country: United States
facility: LA Glaucoma Group /ID# 268444
state: California
city: Vero Beach
country: United States
facility: New Vision Eye Center /ID# 269955
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates - Roswell /ID# 268458
state: Georgia
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
state: Kansas
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants - Minneapolis /ID# 272445
state: Minnesota
city: Omaha
country: United States
facility: Vance Thompson Vision - Omaha /ID# 271599
state: Nebraska
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 269174
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills Eye Hospital Glaucoma Dept /ID# 268569
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates Of Texas /ID# 268745
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons /ID# 268356
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: