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

Phase 4

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: XEN® Gel Stent; Procedure: Cataract Surgery

• Registration Number: NCT02006693
• Lead Sponsor: AqueSys, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-02
• Study Start: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2016-02-09
• Study Completion: 2017-01-26
• Results First Submitted: 2018-06-29
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Results First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XEN® Gel Stent	XEN® Gel Stent	The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
XEN® Gel Stent with Cataract Surgery	Cataract Surgery	The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in IOP in the Study Eyes to Month 24	Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)	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.
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12	Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)	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.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12	Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)	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.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24	Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)	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.

Trial Locations

Locations (21)

University of Graz; 🇦🇹 Graz, Austria

Vienna University; 🇦🇹 Vienna, Austria

Ophthalmology Department of the Military Health Service Institute; 🇵🇱 Warsaw, Poland

Hospital Meixeiro Servicio de Ofthalmologia; 🇪🇸 Vigo, Pontevedra, Spain

Unidad Oftalmologica de Caracas; 🇻🇪 Caracas, Venezuela

University Augenklinik Salzburg; 🇦🇹 Salzburg, Austria

Klinik für Augenheilkunde; 🇩🇪 Frankfurt, Germany

University Eye Clinic Bochum-Langendreer; 🇩🇪 Bochum, Germany

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Principe de Asturias; 🇪🇸 Madrid, Spain

University of Geneva; 🇨🇭 Geneva, Switzerland

Birmingham Midland Eye Theaters; 🇬🇧 Birmingham, West Midlands, United Kingdom

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

St. Thomas Hospital; 🇬🇧 London, United Kingdom

Pinderfields Hospital; 🇬🇧 Wakefield, United Kingdom

Maidstone Hospital Eye, Ear and Mouth Unit; 🇬🇧 Maidstone, Kent, United Kingdom

University of Pisa; 🇮🇹 Pisa, Italy

Clinica Oculistica, Universita' di Torino; 🇮🇹 Torino, Italy

Integrated University Hospital of Verona; 🇮🇹 Verona, Italy

Klinik fur Augenheilkunde; 🇩🇪 Neubrandenburg, Germany