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Trial record 1 of 1 for:    p13-001
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AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02036541
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
AqueSys, Inc.

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE January 15, 2014
Results First Submitted Date  ICMJE May 1, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • 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 ]
    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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
Mean change in IOP from baseline [ Time Frame: 12 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
Official Title  ICMJE A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Glaucoma, Open Angle
Intervention  ICMJE Device: AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
Study Arms  ICMJE Experimental: AqueSys XEN 45 Glaucoma Implant
Intervention: Device: AqueSys XEN 45 Glaucoma Implant
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2017)
65
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
60
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02036541
Other Study ID Numbers  ICMJE P13-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AqueSys, Inc.
Study Sponsor  ICMJE AqueSys, Inc.
Collaborators  ICMJE Allergan
Investigators  ICMJE
Study Chair: Richard A Lewis, M.D. Grutzmacher, Lewis & Sierra Surgical Eye Specialists
PRS Account AqueSys, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP