AqueSys Microfistula Implant in Refractory Glaucoma

Phase 3

Completed

• Conditions: Glaucoma, Open-Angle; Glaucoma
• Interventions: Device: AqueSys Microfistula Implant

• Registration Number: NCT01640756
• Lead Sponsor: AqueSys, Inc.

Brief Summary

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-16
• Primary Completion: 2014-11
• Study Completion: 2015-04
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-11
• Disposition First Submitted QC: 2016-01-11
• Last Update Submitted: 2016-01-11
• Disposition First Posted: 2016-02-08
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 Microfistula Implant	AqueSys Microfistula 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

Secondary Outcome Measures

Name	Time	Method
Mean change in IOP from baseline	12 Months

Trial Locations

Locations (14)

Vold Vision, PLLC; 🇺🇸 Fayetteville, Arkansas, United States

Ophthalmic Consultants of Connecticut; 🇺🇸 Fairfield, Connecticut, United States

USC Eye Institute, University of Southern California; 🇺🇸 Los Angeles, California, United States

Scripps Clinic; 🇺🇸 San Diego, California, United States

Bascom Palmer Eye Institute, University of Miami; 🇺🇸 Miami, Florida, United States

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

Minnesota Eye Consultants, PA; 🇺🇸 Bloomington, Minnesota, United States

Eye Care Associates & Glaucoma Consultants of Long Island; 🇺🇸 Bethpage, New York, United States

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

Vanderbilt Eye Institute; 🇺🇸 Nashville, Tennessee, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

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

UVA Eye Clinic, University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

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