AqueSys Microfistula Implant in Refractory Glaucoma

January 11, 2016 updated by: AqueSys, Inc.

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Vold Vision, PLLC
    • California
      • Los Angeles, California, United States, 90033
        • USC Eye Institute, University of Southern California
      • San Diego, California, United States, 92037
        • Scripps Clinic
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Ophthalmic Consultants of Connecticut
    • Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute, University of Miami
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellence and Glaucoma Institute
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants, PA
    • New York
      • Bethpage, New York, United States, 11714
        • Eye Care Associates & Glaucoma Consultants of Long Island
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Eye Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Texan Eye
      • Dallas, Texas, United States, 75231
        • Glaucoma Associates of Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Eye Clinic, University of Virginia
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AqueSys Microfistula Implant
Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in IOP from baseline
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AqueSys, Inc.

Investigators

  • Study Chair: Richard A Lewis, M.D., Grutzmacher and Lewis Surgical Eye Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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