Primary Open Angle Glaucoma (POAG)DUETTENCT01166659

Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

A study testing CyPass Micro-Stent in people with Primary Open Angle Glaucoma (POAG), run by Transcend Medical, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy Read more about this study

Who is it for?: Ages 21 to 99 years
Conditions the study is for: Primary Open Angle Glaucoma (POAG)
What is being tested?: CyPass Micro-Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: Feb 2010to May 2014
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 21 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of POAG
Medicated IOP ≥ 21 and ≤ 35 mmHg
Use of 1 - 4 topical IOP lowering medications

Who cannot join

Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Use of oral hypotensive medication treatment for glaucoma
Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
Clinically significant ocular pathology other than POAG

About this study

Conditions: Primary Open Angle Glaucoma (POAG)
Being tested: CyPass Micro-Stent
Keywords: Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
Medical subject headings: Glaucoma, Open-Angle, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CyPass Micro-StentDevice
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.

Study groups in NCT01166659
Study group	Role	What they receive
CyPass Micro-Stent	Experimental	Subjects receive the CyPass Micro-Stent Receives: Device: CyPass Micro-Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.
Measured: Baseline; Month 12 postoperative

Secondary outcomes (2)

Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication
Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.
Measured: Month 12 postoperative
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline
The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.
Measured: Baseline, Month 12 postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010May 2014

First posted21 Jul 2010 (estimated)
Study startFeb 2010
Primary completionMay 2013
Study completionMay 2014

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.
Other trials for Primary Open Angle Glaucoma (POAG)Studies 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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01166659
Sponsor's protocol ID: TMI-10-03
Acronym: DUETTE
Status last verified: Oct 2016
First submitted: 14 Jul 2010
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

All Primary Open Angle Glaucoma (POAG) trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
ClinicalTrials.gov ID: NCT01166659
Acronym / sponsor ID: DUETTE / TMI-10-03
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Transcend Medical, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: May 2013 (actual)
Study completion: May 2014 (actual)
First posted: 21 Jul 2010 (estimated)
Results: Posted 28 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CyPass Micro-Stent	Experimental	Device: CyPass Micro-StentSubjects receive the CyPass Micro-Stent

Who may qualify

Ages: 21 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of POAG
Medicated IOP ≥ 21 and ≤ 35 mmHg
Use of 1 - 4 topical IOP lowering medications

Key exclusion criteria (4 listed)

Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Use of oral hypotensive medication treatment for glaucoma
Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
Clinically significant ocular pathology other than POAG

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
CyPass Micro-StentThe CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.	Device	CyPass Micro-Stent

Primary outcome

Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
Time frame: Baseline; Month 12 postoperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.

2 secondary outcomes

Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication
Time frame: Month 12 postoperative
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline
Time frame: Baseline, Month 12 postoperative

Results and safety

Results posted to the registry on 28 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CyPass Micro-Stent	48	35

Primary outcome: Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline

Time frame: Baseline; Month 12 postoperative. Number. Unit: percentage of eyes

Measure	CyPass Micro-Stent n = 42
Value	60.4

Population analysed: Eyes implanted with the CyPass 2FX device with data available.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Ocular Adverse Events	2 of 48 (4.2%)	0 of 48 (0%)	Not reported
Ocular Adverse Events	8 of 50 (16%)	36 of 50 (72%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Open Angle Glaucoma (POAG)

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

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.

Vice President of Medical Affairs study chair

Transcend Medical, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing CyPass Micro-Stent in people with Primary Open Angle Glaucoma (POAG), run by Transcend Medical, Inc..

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 3 inclusion and 4 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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 28 Oct 2016). 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 Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline (time frame: Baseline; Month 12 postoperative). 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 NCT01166659.

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 15 May 2017.