GlaucomaNCT02036541
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
A study testing AqueSys XEN 45 Glaucoma Implant in people with Glaucoma and Glaucoma, Open Angle, run by AqueSys, Inc. at 12 sites in United States.
Trial summary
To establish the safety and performance of the AqueSys XEN 45 Glaucoma 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 XEN 45 Glaucoma Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Glaucoma Associates of Texas
Dallas, Texas, 75231
Vold Vision
Fayetteville, Arkansas, 72704
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525
George R. Reiss, MD PC
Glendale, Arizona, 85306
Montebello Eye Center
Montebello, California, 90640
New York Eye and Ear Infirmary
New York, New York, 10003
San Diego Eye Care Center
Oceanside, California, 92056
Stiles Eyecare Excellence & Glaucoma Institute
Overland Park, Kansas, 66213
Palo Alto Eye Group
Palo Alto, California, 94306
R and R Eye Research, LLC
San Antonio, Texas, 78229
Spokane Eye Clinic
Spokane, Washington, 99204
Washington University in St. Louis, Department of Ophthalmology
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
To establish the safety and performance of the AqueSys XEN 45 Glaucoma 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 XEN 45 Glaucoma Implant in refractory glaucoma patients.
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Being tested
- AqueSys XEN 45 Glaucoma Implant
- Keywords
- Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AqueSys XEN 45 Glaucoma ImplantDevice
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
| Study group | Role | What they receive |
|---|---|---|
| AqueSys XEN 45 Glaucoma Implant | Experimental | Not described Receives: Device: AqueSys XEN 45 Glaucoma 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
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
Measured: 12 Months
Mean Change in IOP From Baseline
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.
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 posted15 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AqueSys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Richard A Lewis, M.D., Study chair, Grutzmacher, Lewis & Sierra Surgical Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036541
- Sponsor's protocol ID
- P13-001
- Status last verified
- May 2017
- First submitted
- 13 Jan 2014
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
PubMed 29267575
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. 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 XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT02036541
- Acronym / sponsor ID
- P13-001
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Keywords
- Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AqueSys, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- Jan 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 1 Jun 2017
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 XEN 45 Glaucoma 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 XEN 45 Glaucoma Implant in refractory glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AqueSys XEN 45 Glaucoma Implant | Experimental | Device: AqueSys XEN 45 Glaucoma 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 XEN 45 Glaucoma ImplantPlacement of the AqueSys XEN 45 Glaucoma Implant in the study eye | Device | AqueSys XEN 45 Glaucoma 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
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
Mean Change in IOP From Baseline
Time frame: 12 Months
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29267575Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
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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, Lewis & Sierra Surgical Eye Specialists
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AqueSys XEN 45 Glaucoma Implant in people with Glaucoma and Glaucoma, Open Angle, run by AqueSys, Inc. at 12 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036541, which also lists 1 linked publication.
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 1 Jun 2017.