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

Phase 4RecruitingNCT05821855

AbbVie130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Open-angle Glaucoma OAG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * 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 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.

Locations (13)

Peking University people s hospital /ID# 265493

Beijing, Beijing Municipality, China

RECRUITING

Peking University Third Hospital /ID# 243994

Beijing, Beijing Municipality, China

RECRUITING

Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital Of Fujian Medical University /ID# 244004

Fuzhou, Fujian, China

RECRUITING

Xiamen Eye Center of Xiamen University /ID# 244000

Xiamen, Fujian, China

COMPLETED

The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493

Guangzhou, Guangdong, China

RECRUITING

Shenzhen Eye Hospital /ID# 244001

Shenzhen, Guangdong, China

RECRUITING

Tongji Hospital Tongji Medical College of HUST /ID# 243998

Wuhan, Hubei, China

RECRUITING

Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992

Qingdao, Shandong, China

RECRUITING

West China Hospital, Sichuan University /ID# 243999

Chengdu, Sichuan, China

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline to Month 60

Secondary Outcomes

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.

Time frame: Baseline to Month 12

Change from Baseline in IOP by Visit

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Month 12

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

Overview

Conditions

Interventions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts