AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036541
• Other study ID #: P13-001
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: May 30, 2017
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: AqueSys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

Locations

Country	Name	City	State
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Vold Vision	Fayetteville	Arkansas
United States	Eye Center of Northern Colorado	Fort Collins	Colorado
United States	George R. Reiss, MD PC	Glendale	Arizona
United States	Montebello Eye Center	Montebello	California
United States	New York Eye and Ear Infirmary	New York	New York
United States	San Diego Eye Care Center	Oceanside	California
United States	Stiles Eyecare Excellence & Glaucoma Institute	Overland Park	Kansas
United States	Palo Alto Eye Group	Palo Alto	California
United States	Washington University in St. Louis, Department of Ophthalmology	Saint Louis	Missouri
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Spokane Eye Clinic	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AqueSys, Inc.	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications	Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.	12 Months
Primary	Mean Change in IOP From Baseline	Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.	12 Months