GlaucomaNCT06176170
VividWhite Glaucoma Implant (VW-51) Pivotal Study
A study testing VividWhite Glaucoma Implant (VW-51) in people with Glaucoma, run by VividWhite Pty Ltd at 6 sites in Australia.
Trial summary
The VividWhite Glaucoma Implant (VW-51) is a novel surgical implant designed to treat glaucoma. This study is a 12-month, 65-participant non-comparative multicentre study to assess the safety and effectiveness of the VW-51 implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- VividWhite Glaucoma Implant (VW-51)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesAustralia
- Study dates
- 12 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
- The glaucoma type is any of the following: Acute Angle Closure Glaucoma (AACG); Chronic Angle Closure Glaucoma where the eye is phakic; Congenital glaucoma; or Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular/rubeotic glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.
- Previous glaucoma surgery with: a tube-and-plate glaucoma drainage device (GDD, e.g. Molteno, Baerveldt, Ahmed, Schocket); an in-situ suprachoroidal implant; or multiple previous operations for glaucoma.
- Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration.
- Central corneal endothelial cell density less than specified age-related thresholds at screening.
- Intraocular silicone oil.
- Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Cataract & Eye Surgery Centre
Doncaster East, Victoria, 3109
Cerulea Clinical Trials, Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Melbourne Eye Specialists
Fitzroy, Victoria, 3065
Sydney Eye Hospital
Sydney, New South Wales, 2000
Eye Surgery Associates
Vermont South, Victoria, 3133
About this study
Official title: A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.
The VividWhite Glaucoma Implant (VW-51) is a novel surgical implant designed to treat glaucoma. This study is a 12-month, 65-participant non-comparative multicentre study to assess the safety and effectiveness of the VW-51 implant.
Read the detailed description
A prospective multicentre non-comparative pivotal clinical study where all participants undergo treatment with a novel surgical implant (VW-51) and receive 12 months of clinical follow-up. The study aim is to assess the effectiveness, safety and participant experience of the VW-51 implant for the treatment of glaucoma. The study population will involve 65 adult participants with medically or surgically refractory glaucoma. The VW-51 implant is a leaf-shaped microfluidic device manufactured from flexible silicone, designed to be surgically implanted in the subconjunctival space, drain aqueous humor from the eye and reduce intraocular pressure to treat glaucoma.
- Conditions
- Glaucoma
- Being tested
- VividWhite Glaucoma Implant (VW-51)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VividWhite Glaucoma Implant (VW-51)Device
Subconjunctival surgical implantation of the VW-51 implant in the study eye.
| Study group | Role | What they receive |
|---|---|---|
| VividWhite Glaucoma Implant (VW-51) | Experimental | Surgical implantation of VW-51. Receives: Device: VividWhite Glaucoma Implant (VW-51) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete success by efficacy and safety criteria
Efficacy Criteria:
- Intraocular pressure (IOP) is less than or equal to 21 mmHg.
- IOP is reduced by greater than or equal to 20% compared to baseline (mean diurnal).
- Treatment with the same number or fewer classes of topical glaucoma medication than at baseline.
- No requirement for: further glaucoma surgery indicated for efficacy (at any time during the study); or systemic/oral ocular hypotensive medication to achieve target IOP in the study eye (at any time during the study). Safety Criteria:
- IOP is greater than or equal to 6 mmHg.
- No adverse events of special significance in the study eye (as specified by the protocol; for example further glaucoma surgery indicated for safety).
Measured: Study completion (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start12 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VividWhite Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Coote, Principal investigator, Melbourne Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176170
- Sponsor's protocol ID
- DF-550
- Status last verified
- Nov 2025
- First submitted
- 10 Dec 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.
- ClinicalTrials.gov ID
- NCT06176170
- Acronym / sponsor ID
- DF-550
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- VividWhite Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 2023 (actual)
- 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.
The VividWhite Glaucoma Implant (VW-51) is a novel surgical implant designed to treat glaucoma. This study is a 12-month, 65-participant non-comparative multicentre study to assess the safety and effectiveness of the VW-51 implant.
Detailed description
A prospective multicentre non-comparative pivotal clinical study where all participants undergo treatment with a novel surgical implant (VW-51) and receive 12 months of clinical follow-up. The study aim is to assess the effectiveness, safety and participant experience of the VW-51 implant for the treatment of glaucoma. The study population will involve 65 adult participants with medically or surgically refractory glaucoma. The VW-51 implant is a leaf-shaped microfluidic device manufactured from flexible silicone, designed to be surgically implanted in the subconjunctival space, drain aqueous humor from the eye and reduce intraocular pressure to treat glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VividWhite Glaucoma Implant (VW-51) | Experimental | Device: VividWhite Glaucoma Implant (VW-51)Surgical implantation of VW-51. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
- The glaucoma type is any of the following: Acute Angle Closure Glaucoma (AACG); Chronic Angle Closure Glaucoma where the eye is phakic; Congenital glaucoma; or Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular/rubeotic glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.
- Previous glaucoma surgery with: a tube-and-plate glaucoma drainage device (GDD, e.g. Molteno, Baerveldt, Ahmed, Schocket); an in-situ suprachoroidal implant; or multiple previous operations for glaucoma.
- Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration.
- Central corneal endothelial cell density less than specified age-related thresholds at screening.
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 |
|---|---|---|
| VividWhite Glaucoma Implant (VW-51)Subconjunctival surgical implantation of the VW-51 implant in the study eye. | Device | VividWhite Glaucoma Implant (VW-51) |
Primary outcome
Complete success by efficacy and safety criteria
Time frame: Study completion (12 months)
Efficacy Criteria: 1. Intraocular pressure (IOP) is less than or equal to 21 mmHg. 2. IOP is reduced by greater than or equal to 20% compared to baseline (mean diurnal). 3. Treatment with the same number or fewer classes of topical glaucoma medication than at baseline. 4. No requirement for: further glaucoma surgery indicated for efficacy (at any time during the study); or systemic/oral ocular hypotensive medication to achieve target IOP in the study eye (at any time during the study). Safety Criteria: 5. IOP is greater than or equal to 6 mmHg. 6. No adverse events of special significance in the study eye (as specified by the protocol; for example further glaucoma surgery indicated for safety).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
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)
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.
Michael Coote principal investigator
Melbourne Eye Specialists
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VividWhite Glaucoma Implant (VW-51) in people with Glaucoma, run by VividWhite Pty Ltd at 6 sites in Australia.
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 0 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Complete success by efficacy and safety criteria (time frame: Study completion (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 18 Nov 2025.