GlaucomaPhase 3NCT00382395
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
A Phase 3 study testing SOLX Gold Shunt GMS-plus and Ahmed FP7 Glaucoma Valve in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 15 sites in 5 countries.
Trial summary
Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open Angle
- What is being tested?
- SOLX Gold Shunt GMS-plus and Ahmed FP7 Glaucoma Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Nov 2005to Jul 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
- Age 21 or over
- refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
- detectable visual field defect (negative MD score)
- written consent
- available for up to 24 months follow-up
Who cannot join
- either eye with VA worse than count fingers
- recent angle closure glaucoma episode
- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
- other significant ocular disease, except cataract
- active ocular infection
- expected ocular surgery in next 12 months
Show all 14Show fewer
- no suitable quadrant for implant
- systemic corticosteroid therapy > 5 mg/day prednisone
- intolerance to gonioscopy or other eye exams
- mental impairment interfering with consent or compliance
- pregnancy
- known sensitivity to anticipated medications used at surgery
- significant co-morbid disease
- concurrent enrollment in another drug or device study
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States9 sites
Price Vision Group
Indianapolis, Indiana, 46260
Glaucoma Consultants of Colorado
Littleton, Colorado, 80120
University of Tennessee / Hamilton Eye Institute
Memphis, Tennessee, 38163
Glaucoma Associates of New York
New York, New York, 10003
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103
North Bay Eye Associates
Petaluma, California, 94954
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
International Eye Care
Tampa, Florida, 33603
Eagle Mountain Vision
Tulsa, Oklahoma, 74132
Canada2 sites
Credit Valley EyeCare
Mississauga, Ontario, L5L 1W8
Institut du Glaucome de Montréal
Montreal, Quebec, H1V 1G5
India2 sites
Vision Research Foundation / Sankara Nethralaya
Chennai, Tamil Nadu, 600 006
Bombay City Eye Institute & Research Centre
Mumbai, Maharashtra, 400 007
About this study
Official title: Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments
Study Objective:
To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.
Read the detailed description
This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Being tested
- SOLX Gold Shunt GMS-plus, Ahmed FP7 Glaucoma Valve
- Keywords
- Glaucoma shunt, Ocular implant, Gold, trabeculectomy
- 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.
SOLX Gold Shunt GMS-plusDevice
Single use implant
Ahmed FP7 Glaucoma ValveDevice
Single use implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SOLX Gold Shunt Receives: Device: SOLX Gold Shunt GMS-plus |
| 2 | Active comparator | Control Ahmed FP7 Shunt Receives: Device: Ahmed FP7 Glaucoma Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in IOP at both 12 and 24 months after implant
Measured: 1 & 2 years
Secondary outcomes (3)
Absolute IOP
Measured: 1 & 2 years
Mean number of glaucoma medications
Measured: 1 & 2 years
Success rate
Measured: 1 & 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOLX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan S. Peterson, MS, RAC, Study director, The Emmes Company, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382395
- Sponsor's protocol ID
- SLX53
- Status last verified
- Sep 2015
- First submitted
- 27 Sep 2006
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments
- ClinicalTrials.gov ID
- NCT00382395
- Acronym / sponsor ID
- SLX53
- Conditions
- Glaucoma, Glaucoma, Open Angle
- Keywords
- Glaucoma shunt, Ocular implant, Gold, trabeculectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SOLX, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Sep 2006 (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.
Study Objective:
To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.
Detailed description
This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SOLX Gold Shunt GMS-plusSOLX Gold Shunt |
| 2 | Active comparator | Device: Ahmed FP7 Glaucoma ValveControl Ahmed FP7 Shunt |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
- Age 21 or over
- refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
- detectable visual field defect (negative MD score)
- written consent
Key exclusion criteria (14 listed)
- either eye with VA worse than count fingers
- recent angle closure glaucoma episode
- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
- other significant ocular disease, except cataract
- active ocular infection
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 |
|---|---|---|
| SOLX Gold Shunt GMS-plusSingle use implant | Device | 1 |
| Ahmed FP7 Glaucoma ValveSingle use implant | Device | 2 |
Primary outcome
Percentage reduction in IOP at both 12 and 24 months after implant
Time frame: 1 & 2 years
3 secondary outcomes
Absolute IOP
Time frame: 1 & 2 years
Mean number of glaucoma medications
Time frame: 1 & 2 years
Success rate
Time frame: 1 & 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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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.
Jan S. Peterson, MS, RAC study director
The Emmes Company, LLC
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOLX Gold Shunt GMS-plus and Ahmed FP7 Glaucoma Valve in people with Glaucoma and Glaucoma, Open Angle, run by SOLX, Inc. at 15 sites in 5 countries.
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 6 inclusion and 14 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: paused, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, India, Israel, Poland. 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?
Results are not available in the source record.
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?
Percentage reduction in IOP at both 12 and 24 months after implant (time frame: 1 & 2 years). 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 18 Sep 2015.