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Recruiting 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

Phase III Interventional Primary Open Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XEN63 Glaucoma Treatment System.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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 the United States. 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.

Interventions

  • Device XEN63 Glaucoma Treatment System
    Gel Stent

Primary outcome measures

  • 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 [Time frame: Month 12]
  • Number of Participants with Adverse Events (AEs) [Time frame: Month 12]
Secondary outcome measures (4)
  • Mean Diurnal IOP [Time frame: Month 12]
  • Change From Baseline in Diurnal IOP [Time frame: Baseline to Month 12]
  • Change from Baseline in Number of Topical IOP-Lowering Medications [Time frame: Baseline to Month 12]
  • Mean Number of Topical IOP-Lowering Medications [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 27 centers
  • Arizona Advanced Eye Research Institute /ID# 268363 — Glendale
  • LA Glaucoma Group /ID# 268444 — Culver City
  • North Bay Eye Associates /ID# 277071 — Petaluma
  • University Of Colorado - Anschutz Medical Campus /ID# 269947 — Aurora
  • Colorado Eye Institute /ID# 277072 — Colorado Springs
  • Eye Center of Northern Colorado /ID# 281798 — Fort Collins
  • Brandon Eye Associates - Brandon /ID# 277074 — Brandon
  • East Coast Institute for Research /ID# 280411 — Jacksonville
  • … and 19 more centers

Identifiers

NCT: NCT06822738 · M22-087

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗