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

NCT02006693 | Completed Phase 4 Results

• 1 other identifier: MS-001
• Study Type: interventional
• Target: 199
• Locations: 9 countries
• Sites: 21

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.

Conditions

Primary Open Angle Glaucoma

Keywords

XEN; Primary Open Angle Glaucoma; Filtration Device; Ab interno

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

XEN® Gel Stent

OTHER

The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.

Device: XEN® Gel Stent

XEN® Gel Stent with Cataract Surgery

OTHER

The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Procedure: Cataract Surgery

Interventions

XEN® Gel Stent DEVICE

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

Also known as: XEN Glaucoma Implant, XEN Gel Stent, XEN45 Implant

XEN® Gel Stent

Cataract Surgery PROCEDURE

Participants diagnosed with a cataract elected to have cataract surgery.

XEN® Gel Stent with Cataract Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary open angle glaucoma
• Participants are taking at least one and no more than four topical IOP-lowering medications.

You may not qualify if:

• 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

Sponsors & Collaborators

• AqueSys, Inc.: lead

Study Sites (21)

University of Graz

Graz, 8036, Austria

Location

University Augenklinik Salzburg

Salzburg, 5020, Austria

Location

Vienna University

Vienna, 1090, Austria

Location

University Hospitals Leuven

Leuven, B-3000, Belgium

Location

University Eye Clinic Bochum-Langendreer

Bochum, 44892, Germany

Location

Klinik für Augenheilkunde

Frankfurt, D-60590, Germany

Location

Klinik fur Augenheilkunde

Neubrandenburg, 17036, Germany

Location

University of Pisa

Pisa, 56124, Italy

Location

Clinica Oculistica, Universita' di Torino

Torino, 10100, Italy

Location

Integrated University Hospital of Verona

Verona, 37126, Italy

Location

Ophthalmology Department of the Military Health Service Institute

Warsaw, 04-141, Poland

Location

Hospital Meixeiro Servicio de Ofthalmologia

Vigo, Pontevedra, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Principe de Asturias

Madrid, Spain

Location

University of Geneva

Geneva, 1211, Switzerland

Location

Maidstone Hospital Eye, Ear and Mouth Unit

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

Birmingham Midland Eye Theaters

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V2PD, United Kingdom

Location

St. Thomas Hospital

London, SE17EH, United Kingdom

Location

Pinderfields Hospital

Wakefield, WF14DG, United Kingdom

Location

Unidad Oftalmologica de Caracas

Caracas, Venezuela

Location

Related Publications (2)

• Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.

  PMID: 30758653 DERIVED

• Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.

  PMID: 29267575 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Vanessa Vera, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 10, 2013
• Study Start: December 5, 2013
• Primary Completion: February 9, 2016
• Study Completion: January 26, 2017
• Last Updated: April 22, 2019
• Results First Posted: April 22, 2019

Record last verified: 2019-01

Locations

PL (1); AU (3); GB (5); ES (3); DE (3); IT (3); VE (1); BE (1); CH (1)