AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma; Glaucoma, Open Angle
• Interventions: Device: AqueSys XEN 45 Glaucoma Implant

• Registration Number: NCT02036541
• Lead Sponsor: AqueSys, Inc.

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2016-02
• Study Completion: 2016-08
• Status Verified: 2017-05
• Results First Submitted: 2017-05-01
• Results First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AqueSys XEN 45 Glaucoma Implant	AqueSys XEN 45 Glaucoma Implant	-

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications	12 Months	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.
Mean Change in IOP From Baseline	12 Months	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.

Trial Locations

Locations (12)

Stiles Eyecare Excellence & Glaucoma Institute; 🇺🇸 Overland Park, Kansas, United States

Montebello Eye Center; 🇺🇸 Montebello, California, United States

San Diego Eye Care Center; 🇺🇸 Oceanside, California, United States

Spokane Eye Clinic; 🇺🇸 Spokane, Washington, United States

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

Washington University in St. Louis, Department of Ophthalmology; 🇺🇸 Saint Louis, Missouri, United States

George R. Reiss, MD PC; 🇺🇸 Glendale, Arizona, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Eye Center of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

Palo Alto Eye Group; 🇺🇸 Palo Alto, California, United States

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States

R and R Eye Research, LLC; 🇺🇸 San Antonio, Texas, United States