AqueSys Microfistula Implant in Refractory Glaucoma
This study is currently recruiting participants.
Verified February 2013 by AqueSys, Inc.
Sponsor:
AqueSys, Inc.
Information provided by (Responsible Party):
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT01640756
First received: July 12, 2012
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Glaucoma, Open-Angle |
Device: AqueSys Microfistula Implant |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by AqueSys, Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change in IOP from baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AqueSys Microfistula Implant |
Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Primary Open Angle Glaucoma (POAG)
- Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
- Failed a previous incisional glaucoma surgery or cilioablative procedure
- Visual field mean deviation score of -3 dB or worse
- Area of free, healthy and mobile conjunctiva in the targeted quadrant
Exclusion Criteria:
- Any other glaucoma diagnosis other than POAG
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640756
Contacts
| Contact: Rupali Jobanputra | 949-450-0250 ext 223 | RJobanputra@AqueSys.com |
Locations
| United States, Arkansas | |
| Vold Vision, PLLC | Recruiting |
| Fayetteville, Arkansas, United States, 72704 | |
| United States, California | |
| Doheny Eye Institute, University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Scripps Clinic | Recruiting |
| San Diego, California, United States, 92037 | |
| Glaucoma Center of San Francisco | Recruiting |
| San Francisco, California, United States, 94105 | |
| United States, Connecticut | |
| Ophthalmic Consultants of Connecticut | Recruiting |
| Fairfield, Connecticut, United States, 06824 | |
| United States, Florida | |
| Bascom Palmer Eye Institute, University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Kansas | |
| Stiles Eyecare Excellence and Glaucoma Institute | Recruiting |
| Overland Park, Kansas, United States, 66213 | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Minnesota Eye Consultants, PA | Recruiting |
| Bloomington, Minnesota, United States, 55431 | |
| United States, Pennsylvania | |
| Wills Eye Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Vanderbilt Eye Institute | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Glaucoma Associates of Texas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| United States, Washington | |
| Spokane Eye Clinic | Recruiting |
| Spokane, Washington, United States, 99204 | |
Sponsors and Collaborators
AqueSys, Inc.
Investigators
| Study Chair: | Richard A Lewis, M.D. | Grutzmacher and Lewis Surgical Eye Specialists |
More Information
No publications provided
| Responsible Party: | AqueSys, Inc. |
| ClinicalTrials.gov Identifier: | NCT01640756 History of Changes |
| Other Study ID Numbers: | P11-001 |
| Study First Received: | July 12, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AqueSys, Inc.:
|
Glaucoma Implant Trabeculectomy POAG |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013