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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01640756
Other study ID # P11-001
Secondary ID
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


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
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