Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Primary Open Angle Glaucoma Clinical Trial

Official title:

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006693
• Other study ID #: MS-001
• Status: Completed
• Phase: Phase 4
• Start date: December 5, 2013
• Est. completion date: January 26, 2017

Study information

• Verified date: January 2019
• Source: AqueSys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 26, 2017
• Est. primary completion date: February 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of primary open angle glaucoma

• Participants are taking at least one and no more than four topical IOP-lowering medications.

Exclusion Criteria:

• Angle Closure Glaucoma

• Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders

• Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)

• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• XEN® Gel Stent
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.

Procedure:
• Cataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.

Locations

Country	Name	City	State
Austria	University of Graz	Graz
Austria	University Augenklinik Salzburg	Salzburg
Austria	Vienna University	Vienna
Belgium	University Hospitals Leuven	Leuven
Germany	University Eye Clinic Bochum-Langendreer	Bochum
Germany	Klinik für Augenheilkunde	Frankfurt
Germany	Klinik fur Augenheilkunde	Neubrandenburg
Italy	University of Pisa	Pisa
Italy	Clinica Oculistica, Universita' di Torino	Torino
Italy	Integrated University Hospital of Verona	Verona
Poland	Ophthalmology Department of the Military Health Service Institute	Warsaw
Spain	Hospital Principe de Asturias	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Meixeiro Servicio de Ofthalmologia	Vigo	Pontevedra
Switzerland	University of Geneva	Geneva
United Kingdom	Birmingham Midland Eye Theaters	Birmingham	West Midlands
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	St. Thomas Hospital	London
United Kingdom	Maidstone Hospital Eye, Ear and Mouth Unit	Maidstone	Kent
United Kingdom	Pinderfields Hospital	Wakefield
Venezuela	Unidad Oftalmologica de Caracas	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
AqueSys, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12	IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.	Baseline (= 90 days Preoperative) to Month 12 (Postoperative)
Primary	Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12	The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.	Baseline (= 90 days Preoperative) to Month 12 (Postoperative)
Primary	Mean Change From Baseline in IOP in the Study Eyes to Month 24	IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.	Baseline (= 90 days Preoperative) to Month 24 (Postoperative)
Primary	Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24	The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.	Baseline (= 90 days Preoperative) to Month 24 (Postoperative)