AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT02036541
First received: January 13, 2014
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

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


Condition Intervention Phase
Glaucoma
Glaucoma, Open Angle
Device: AqueSys XEN 45 Glaucoma Implant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AqueSys, Inc.:

Primary Outcome Measures:
  • Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in IOP from baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AqueSys XEN 45 Glaucoma Implant Device: AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036541

Locations
United States, Arizona
George R. Reiss, MD PC
Glendale, Arizona, United States, 85306
United States, Arkansas
Vold Vision
Fayetteville, Arkansas, United States, 72704
United States, California
Montebello Eye Center
Montebello, California, United States, 90640
San Diego Eye Care Center
Oceanside, California, United States, 92056
Palo Alto Eye Group
Palo Alto, California, United States, 94306
United States, Colorado
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525
United States, Kansas
Stiles Eyecare Excellence & Glaucoma Institute
Overland Park, Kansas, United States, 66213
United States, Missouri
Washington University in St. Louis, Department of Ophthalmology
St. Louis, Missouri, United States, 63110
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
R and R Eye Research, LLC
San Antonio, Texas, United States, 78229
United States, Washington
Spokane Eye Clinic
Spokane, Washington, United States, 99204
Sponsors and Collaborators
AqueSys, Inc.
Investigators
Study Chair: Richard A Lewis, M.D. Grutzmacher, Lewis & Sierra Surgical Eye Specialists
  More Information

No publications provided

Responsible Party: AqueSys, Inc.
ClinicalTrials.gov Identifier: NCT02036541     History of Changes
Other Study ID Numbers: P13-001
Study First Received: January 13, 2014
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AqueSys, Inc.:
Glaucoma Implant
Trabeculectomy
POAG
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on August 31, 2015