Clinical trial NCT02036541: AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Glaucoma, Open Angle
Keywords: Glaucoma Implant
Trabeculectomy
POAG
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma
Lead sponsor: AqueSys, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2014-01-15
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Detailed description: A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Refractory Glaucoma
* Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
* Visual field mean deviation score of -3 dB or worse
* Shaffer Angle Grade ≥ 3
* Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

* Active Neovascular Glaucoma
* Previous glaucoma shunt/valve in the targeted quadrant
* History of corneal surgery, opacities or disease/pathology
* Anticipated need for ocular surgery
* Non-study eye with BCVA of 20/200 or worse

Primary outcomes:
measure: Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
timeFrame: 12 Months
measure: Mean Change in IOP From Baseline
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: George R. Reiss, MD PC
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Montebello
country: United States
facility: Montebello Eye Center
state: California
city: Oceanside
country: United States
facility: San Diego Eye Care Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Eye Group
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence & Glaucoma Institute
state: Kansas
city: Saint Louis
country: United States
facility: Washington University in St. Louis, Department of Ophthalmology
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
affiliation: Grutzmacher, Lewis & Sierra Surgical Eye Specialists
name: Richard A Lewis, M.D.
role: STUDY_CHAIR
References:
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.