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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XEN45 | Experimental | Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. |
|
| Trabeculectomy | Active Comparator | Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN45 Glaucoma Treatment System | Device | Ab interno implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Intraocular Pressure (IOP) | 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. | Baseline to Month 12 |
| Number of Participants with Adverse Events (AEs) | 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. | Baseline to Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction | 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. | Baseline to Month 12 |
| Change from Baseline in IOP by Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University people s hospital /ID# 265493 | Beijing | Beijing Municipality | 100044 | China | ||
| Peking University Third Hospital /ID# 243994 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Trabeculectomy |
| Procedure |
Surgical Intervention |
|
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. |
| Baseline to Month 12 |
| Change from Baseline in Number of Topical IOP-Lowering Medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 12 |
| Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications | 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. | Baseline to Month 12 |
| Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications | 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. | Baseline to Month 12 |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055 | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital Of Fujian Medical University /ID# 244004 | Fuzhou | Fujian | 350005 | China |
| Xiamen Eye Center of Xiamen University /ID# 244000 | Xiamen | Fujian | 390000 | China |
| The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493 | Guangzhou | Guangdong | 510260 | China |
| Shenzhen Eye Hospital /ID# 244001 | Shenzhen | Guangdong | 518034 | China |
| Tongji Hospital Tongji Medical College of HUST /ID# 243998 | Wuhan | Hubei | 430030 | China |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992 | Qingdao | Shandong | 266071 | China |
| West China Hospital, Sichuan University /ID# 243999 | Chengdu | Sichuan | 610041 | China |
| Tianjin Eye Hospital /ID# 243997 | Tianjin | Tianjin Municipality | 300070 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996 | Hangzhou | Zhejiang | 310009 | China |
| Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843 | Guangzhou | 510623 | China |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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