AqueSys Microfistula Implant in Refractory Glaucoma

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640756
• Other study ID #: P11-001
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2012
• Last updated: January 11, 2016
• Start date: July 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: AqueSys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To establish the safety and performance of the AqueSys Microfistula 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 Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Eye Care Associates & Glaucoma Consultants of Long Island	Bethpage	New York
United States	Minnesota Eye Consultants, PA	Bloomington	Minnesota
United States	UVA Eye Clinic, University of Virginia	Charlottesville	Virginia
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Ophthalmic Consultants of Connecticut	Fairfield	Connecticut
United States	Vold Vision, PLLC	Fayetteville	Arkansas
United States	USC Eye Institute, University of Southern California	Los Angeles	California
United States	Bascom Palmer Eye Institute, University of Miami	Miami	Florida
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	New York Eye and Ear Infirmary	New York	New York
United States	Stiles Eyecare Excellence and Glaucoma Institute	Overland Park	Kansas
United States	Scripps Clinic	San Diego	California
United States	Spokane Eye Clinic	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AqueSys, Inc.

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		12 Months	No
Secondary	Mean change in IOP from baseline		12 Months	No