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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство XEN63 Glaucoma Treatment System
  Gel Stent

Первичные конечные точки

• 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 [Срок оценки: Month 12]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Month 12]

Вторичные конечные точки (4)

• Mean Diurnal IOP [Срок оценки: Month 12]
• Change From Baseline in Diurnal IOP [Срок оценки: Baseline to Month 12]
• Change from Baseline in Number of Topical IOP-Lowering Medications [Срок оценки: Baseline to Month 12]
• Mean Number of Topical IOP-Lowering Medications [Срок оценки: Month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 27 центров

• 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
• … и ещё 19 центров

Идентификаторы

NCT: NCT06822738 · M22-087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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