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

Open-angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821855
• Other study ID #: 1924-802-007
• Status: Recruiting
• Phase: Phase 4
• Start date: December 8, 2023
• Est. completion date: July 13, 2030

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 13, 2030
• Est. primary completion date: July 13, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Device:
• XEN45 Glaucoma Treatment System
Ab interno implantation

Procedure:
• Trabeculectomy
Surgical Intervention

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, CMU /ID# 244055	Beijing
China	Peking University Third Hospital /ID# 243994	Beijing	Beijing
China	West China Hospital, Sichuan University /ID# 243999	Chengdu	Sichuan
China	The First Affiliated Hospital Of Fujian Medical University /ID# 244004	Fuzhou	Fujian
China	Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843	Guangzhou
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 243996	Hangzhou	Zhejiang
China	Qingdao Eye Hospital of Shandong First Medical University /ID# 243992	Qingdao
China	Shenzhen Eye Hospital /ID# 244001	Shenzhen	Guangdong
China	Tianjin Eye Hospital /ID# 243997	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 243998	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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