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

Study Overview
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Brief Summary
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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.

Official Title
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A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China

Conditions
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Open-angle Glaucoma, OAG

Intervention / Treatment
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* Device: XEN45 Glaucoma Treatment System
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Medicated IOP => 20 mm Hg and <= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit. Exclusion Criteria: Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XEN45<br>Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. | Device: XEN45 Glaucoma Treatment System<br>* Ab interno implantation<br>|
| Active Comparator: Trabeculectomy<br>Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months. | Procedure: Trabeculectomy<br>* Surgical Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (Medicated) in Mean 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 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. | Baseline to Month 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving => 20% Mean IOP Reduction | Effectiveness rate is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications with no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention. | Baseline to Month 12 | 
| Change from baseline (medicated) in mean 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 | 
| Change from baseline in mean 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 success rate is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of intraocular pressure (IOP) without topical glaucoma 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 success rate 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP