A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China
- Conditions
- Open-angle GlaucomaOAG
- Interventions
- Device: XEN45 Glaucoma Treatment SystemProcedure: Trabeculectomy
- Registration Number
- NCT05821855
- Lead Sponsor
- AbbVie
- Brief Summary
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. The purpose of this study is to assess adverse events (AEs) and changes in disease activity in participants with open-angle glaucoma (OAG) receiving the XEN45 Glaucoma Treatment System (XEN45).
XEN45 is an approved device for the treatment of OAG in participants in China who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (IOP)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. Adult participants with a diagnosis of OAG will be randomized to receive either XEN 45 or trabeculectomy. Around 130 participants will be enrolled in the study at approximately 15 sites in China.
Participants will receive XEN45 implanted using the ab interno approach or trabeculectomy on Day 1 and will be followed for 60 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva.
- Visible trabecular meshwork with Shaffer angle grade => 3 in the study eye at the Screening Visit.
- IOP => 20 mm Hg and <= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit.
- Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye.
- Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XEN45 XEN45 Glaucoma Treatment System Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. Trabeculectomy Trabeculectomy Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.
- Primary Outcome Measures
Name Time Method Change from Baseline in Intraocular Pressure (IOP) Baseline to Month 12 IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Number of Participants with Adverse Events (AEs) Baseline to Month 60 An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction Baseline to Month 12 Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications without secondary surgical intervention (SSI) for uncontrolled IOP.
Change from Baseline in IOP by Visit Baseline to Month 12 IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change from Baseline in Number of Topical IOP-Lowering Medications Baseline to Month 12 A numerical count by class of drug of topical IOP lowering medications being taken.
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications Baseline to Month 12 The complete treatment response is defined as the percentage of participants achieving IOP \<=18 mm Hg and 20% or more reduction of IOP without topical IOP medications from baseline.
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications Baseline to Month 12 The qualified treatment response is defined as the percentage of participants achieving IOP \<= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications.
Trial Locations
- Locations (12)
Peking University people's hospital /ID# 265493
🇨🇳Beijing, Beijing, China
Peking University Third Hospital /ID# 243994
🇨🇳Beijing, Beijing, China
Xiamen Eye Center of Xiamen University /ID# 244000
🇨🇳Xiamen, Fujian, China
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Fujian Medical University /ID# 244004
🇨🇳Fuzhou, Fujian, China
Shenzhen Eye Hospital /ID# 244001
🇨🇳Shenzhen, Guangdong, China
Tongji Hospital Tongji Medical College of HUST /ID# 243998
🇨🇳Wuhan, Hubei, China
West China Hospital, Sichuan University /ID# 243999
🇨🇳Chengdu, Sichuan, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 243996
🇨🇳Hangzhou, Zhejiang, China
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
🇨🇳Guangzhou, China
Qingdao Eye Hospital of Shandong First Medical University /ID# 243992
🇨🇳Qingdao, Shandong, China
Tianjin Eye Hospital /ID# 243997
🇨🇳Tianjin, Tianjin, China