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AqueSys Microfistula Implant in Refractory Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT01640756
First received: July 12, 2012
Last updated: November 7, 2013
Last verified: November 2013

July 12, 2012
November 7, 2013
July 2012
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01640756 on ClinicalTrials.gov Archive Site
Mean change in IOP from baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AqueSys Microfistula Implant in Refractory Glaucoma
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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Glaucoma, Open-Angle
Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye
Experimental: AqueSys Microfistula Implant
Intervention: Device: AqueSys Microfistula Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
May 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01640756
P11-001
No
AqueSys, Inc.
AqueSys, Inc.
Not Provided
Study Chair: Richard A Lewis, M.D. Grutzmacher and Lewis Surgical Eye Specialists
AqueSys, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP