NCT03654885已完成4 期
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 158
- 试验地点
- 70
- 主要终点
- Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.
详细描述
This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open-angle glaucoma where the intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication
- •Best-corrected baseline Snellen visual acuity of 20/100 or better
- •Visual field mean deviation no worse than -18.0 decibels (dB)
- •Medicated IOP ≥15 millimeter of mercury (mm Hg) and ≤44 mm Hg
- •Participants not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 3 months from the time of inclusion
- •Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)
- •Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target quadrant)
- •Failed ab-interno canal or suprachoroidal micro invasive glaucoma surgery (MIGS) procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT], Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed ≥3 months before enrollment. CyPass® Micro-Stents were not allowed.
排除标准
- •Participant has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- •Participant has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, ultrasound circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle)
- •Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)
- •Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area
- •History of corneal surgery, corneal opacities, or corneal disease
- •Central corneal thickness ≤490 micrometer (μm) or ≥620μm
- •Vitreous present in the anterior chamber
- •Participant has had prior intraocular surgery in either eye within ≤3 months before the preoperative visit (including phacoemulsification)
- •History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [CME], etc.)
- •Presence of intraocular silicone oil
- •Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, iridocorneal endothelial syndrome [ICE], etc.)
- •Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)
- •Pregnant or nursing women and those planning a pregnancy during the study period.
- •Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit
结局指标
主要结局
Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats
时间窗: Baseline (Preoperative) to Month 12
IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
次要结局
- Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time(Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12)
- Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs)(Median follow-up of 366.0 days)
- Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores(Baseline (Preoperative) to Month 6)
- Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading(Baseline (Preoperative) and Month 12)
- PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine(Month 3)
- Percentage of Participants With Clinical Hypotony(Month 12)
- Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye(Month 12)
- Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy(Month 12)
- Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy(Month 12)
- Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy(Month 12)
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses(Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12)
- Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs)(Median follow-up of 366.0 days)
- Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up(Baseline up to Month 12)
- Pachymetry Based on Change From Baseline In Average Central Corneal Thickness(Baseline (Preoperative) and Month 12)
- Change From Baseline in Visual Field Examinations Analyzed by Machine Type(Baseline and Month 12)
- Percentage of Participants Achieving Qualified Success at Month 12(Month12)
- Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes(Month 12)
- Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration(Month 12)
- Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale(Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12)
- Percentage of Participants With Antifibrotic Use During Needling(Up to Month 12)
- Mean IOP Over Time(Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12)
- Change From Baseline in Mean IOP Over Time(Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12)
- Mean Number of Topical IOP-Lowering Medications Over Time(Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12)
- Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12(Baseline (Preoperative) and Month 12)
- Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use(Month 12)
- PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health(Baseline (Preoperative) and Month 12)
- Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy(Month 12)
- Mean Surgically Induced Astigmatism - Autorefractor Reading(Month 12)
- Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites(Baseline (Preoperative), Week 1, and Months 1 and 12)
- Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth(Baseline, Day 1 and Week 2)
- Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites(Up to Month 12)
- Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs)(Median follow-up of 366.0 days)
- Change From Baseline in Mean IOP at Month 12(Baseline (Preoperative) and Month 12)
- Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg(Baseline (Preoperative) and Month 12)
- Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings(Month 12)
- PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health(Baseline (Preoperative) and Month 12)
- Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg(Baseline (Preoperative) and Month 12)
- Percentage of Participants Achieving Specific IOP Targets at Month 12(Month 12)
- Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12(Baseline (Preoperative) and Month 12)
- Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D(Baseline, Day 1 and Week 2)
- Bleb Morphology - Slit Lamp Photography at Selected Sites(Up to Month 12)
- Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment(Up to Month 12)
- Percentage of Participants With Needlings Performed(Up to Month 12)
- Mean Number of Needlings Per Eye(Up to Month 12)
- Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings(Month 12)
- Percentage of Participants Achieving Complete Success at Month 12(Month 12)
- Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12(Baseline (Preoperative) to Month 12)
研究者
研究点 (70)
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