Clinical trial NCT02006693: Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Official title: Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Keywords: XEN
Primary Open Angle Glaucoma
Filtration Device
Ab interno
Lead sponsor: AqueSys, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
timeFrame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
measure: Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
timeFrame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
measure: Mean Change From Baseline in IOP in the Study Eyes to Month 24
timeFrame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
measure: Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
timeFrame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University of Graz
city: Salzburg
country: Austria
facility: University Augenklinik Salzburg
city: Vienna
country: Austria
facility: Vienna University
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Bochum
country: Germany
facility: University Eye Clinic Bochum-Langendreer
city: Frankfurt
country: Germany
facility: Klinik für Augenheilkunde
city: Neubrandenburg
country: Germany
facility: Klinik fur Augenheilkunde
city: Pisa
country: Italy
facility: University of Pisa
city: Torino
country: Italy
facility: Clinica Oculistica, Universita' di Torino
city: Verona
country: Italy
facility: Integrated University Hospital of Verona
city: Warsaw
country: Poland
facility: Ophthalmology Department of the Military Health Service Institute
city: Vigo
country: Spain
facility: Hospital Meixeiro Servicio de Ofthalmologia
state: Pontevedra
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Principe de Asturias
city: Geneva
country: Switzerland
facility: University of Geneva
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital Eye, Ear and Mouth Unit
state: Kent
city: Birmingham
country: United Kingdom
facility: Birmingham Midland Eye Theaters
state: West Midlands
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
city: Caracas
country: Venezuela
facility: Unidad Oftalmologica de Caracas
Study officials:
affiliation: Allergan
name: Vanessa Vera, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.