GlaucomaPhase 3NCT01640756
AqueSys Microfistula Implant in Refractory Glaucoma
A Phase 3 study testing AqueSys Microfistula Implant in people with Glaucoma and Glaucoma, Open-Angle, run by AqueSys, Inc. at 14 sites in United States.
Trial summary
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle
- What is being tested?
- AqueSys Microfistula Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2012to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Texan Eye
Austin, Texas, 78731
Eye Care Associates & Glaucoma Consultants of Long Island
Bethpage, New York, 11714
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431
UVA Eye Clinic, University of Virginia
Charlottesville, Virginia, 22903
Glaucoma Associates of Texas
Dallas, Texas, 75231
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824
Vold Vision, PLLC
Fayetteville, Arkansas, 72704
USC Eye Institute, University of Southern California
Los Angeles, California, 90033
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
New York Eye and Ear Infirmary
New York, New York, 10003
Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas, 66213
Scripps Clinic
San Diego, California, 92037
Spokane Eye Clinic
Spokane, Washington, 99204
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Being tested
- AqueSys Microfistula Implant
- Keywords
- Glaucoma Implant, Trabeculectomy, POAG
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AqueSys Microfistula ImplantDevice
Placement of the AqueSys Microfistula Implant in the study eye
| Study group | Role | What they receive |
|---|---|---|
| AqueSys Microfistula Implant | Experimental | Not described Receives: Device: AqueSys Microfistula Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications
Measured: 12 Months
Secondary outcomes (1)
Mean change in IOP from baseline
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AqueSys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Lewis, M.D., Study chair, Grutzmacher and Lewis Surgical Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640756
- Sponsor's protocol ID
- P11-001
- Status last verified
- Jan 2016
- First submitted
- 12 Jul 2012
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT01640756
- Acronym / sponsor ID
- P11-001
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Keywords
- Glaucoma Implant, Trabeculectomy, POAG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AqueSys, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AqueSys Microfistula Implant | Experimental | Device: AqueSys Microfistula Implant |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AqueSys Microfistula ImplantPlacement of the AqueSys Microfistula Implant in the study eye | Device | AqueSys Microfistula Implant |
Primary outcome
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
1 secondary outcome
Mean change in IOP from baseline
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Lewis, M.D. study chair
Grutzmacher and Lewis Surgical Eye Specialists
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AqueSys Microfistula Implant in people with Glaucoma and Glaucoma, Open-Angle, run by AqueSys, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.