GlaucomaNCT00834223
A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)
A study testing Aquashunt in people with Glaucoma, run by OPKO Health, Inc. at 1 site in Dominican Republic.
Trial summary
A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Aquashunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jan 2009to May 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex will be eligible for the study if all of the following criteria are met:
- Patients must be aged 18 years or more.
- Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
- The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
- Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
- Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
- Patients must be mentally competent and willing to provide informed consent.
- Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.
Who cannot join
- Patients will not be eligible for the study if any of the following criteria are present:
- Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
- Patients with clinically significant corneal disease including corneal dystrophy.
- Patients with iridocorneal endothelial syndrome.
- Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
- Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
Show all 12Show fewer
- Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
- Patients with a history of extensive keloid formation.
- Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.
- Patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device.
- Patients who are unable to interrupt their anti-coagulant, anti-platelet or NSAID (including aspirin) therapy for at least 3 weeks prior to surgery.
- Patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG
- Conditions
- Glaucoma
- Being tested
- Aquashunt
- Keywords
- refractory chronic forms of open angle glaucoma (OAG), OAG, glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquashuntDevice
A shunt which is implanted into the suprachoroidal space.
| Study group | Role | What they receive |
|---|---|---|
| Aquashunt | Other | Open label, all subjects receive device. Receives: Device: Aquashunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
Measured: 6 and 12 months
Secondary outcomes (2)
Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation.
Measured: 6 and 12 months
Safety measures: The incidence of device and procedure-related complications. All adverse events reported, whether deemed related to the treatment or not.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionMay 2010
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naveen Shams, MD PhD, Study director, Opko Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834223
- Sponsor's protocol ID
- OPK-04-101
- Status last verified
- Mar 2011
- First submitted
- 2 Feb 2009
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT00834223
- Acronym / sponsor ID
- OPK-04-101
- Conditions
- Glaucoma
- Keywords
- refractory chronic forms of open angle glaucoma (OAG), OAG, glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Feb 2009 (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.
A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquashunt | Other | Device: AquashuntOpen label, all subjects receive device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of either sex will be eligible for the study if all of the following criteria are met:
- Patients must be aged 18 years or more.
- Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
- The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
- Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
Key exclusion criteria (12 listed)
- Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
- Patients with clinically significant corneal disease including corneal dystrophy.
- Patients with iridocorneal endothelial syndrome.
- Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
- Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
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 |
|---|---|---|
| AquashuntA shunt which is implanted into the suprachoroidal space. | Device | Aquashunt |
Primary outcome
Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
Time frame: 6 and 12 months
2 secondary outcomes
Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation.
Time frame: 6 and 12 months
Safety measures: The incidence of device and procedure-related complications. All adverse events reported, whether deemed related to the treatment or not.
Time frame: 3 years
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 1 Apr 2011.
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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.
Naveen Shams, MD PhD study director
Opko Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquashunt in people with Glaucoma, run by OPKO Health, Inc. at 1 site in Dominican Republic.
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 8 inclusion and 12 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 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. 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?
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?
Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation. (time frame: 6 and 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 1 Apr 2011.