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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 49
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
XEN63 Ab Externo
Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
干预措施: XEN63 Glaucoma Treatment System (Device)
XEN63 Ab Interno
Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
干预措施: XEN63 Glaucoma Treatment System (Device)
结局指标
主要结局
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
时间窗: 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)
时间窗: 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.
次要结局
- Mean Diurnal IOP(Month 12)
- Change From Baseline in Diurnal IOP(Baseline to Month 12)
- Change from Baseline in Number of Topical IOP-Lowering Medications(Baseline to Month 12)
- Mean Number of Topical IOP-Lowering Medications(Month 12)