New implant for treating glaucoma
A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.
NA · VividWhite Pty Ltd · NCT06176170
This study is testing a new implant for treating glaucoma to see if it safely helps people with high eye pressure feel better over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VividWhite Pty Ltd (industry) |
| Locations | 6 sites (Sydney, New South Wales and 5 other locations) |
| Trial ID | NCT06176170 on ClinicalTrials.gov |
What this trial studies
The VividWhite Glaucoma Implant (VW-51) is a novel surgical device aimed at treating glaucoma by draining aqueous humor from the eye to reduce intraocular pressure. This multicentre study involves 65 adult participants with refractory glaucoma who will receive the VW-51 implant and undergo 12 months of clinical follow-up. The primary focus is to evaluate the safety, effectiveness, and overall participant experience with the implant. The device is designed to be surgically implanted in the subconjunctival space, utilizing a microfluidic mechanism for optimal performance.
Who should consider this trial
Good fit: Ideal candidates include adults with medically or surgically refractory glaucoma who have not achieved adequate intraocular pressure control.
Not a fit: Patients with glaucoma that is not refractory or those who have had multiple previous surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this implant could provide a new treatment option for patients with difficult-to-manage glaucoma.
How similar studies have performed: While this approach is novel, similar studies involving microfluidic devices for glaucoma treatment have shown promise in preliminary investigations.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: Glaucoma in the study eye, meeting the following requirements: 1. Glaucoma is diagnosed by the investigator based upon untreated intraocular pressure, disc appearance and visual field abnormalities, and where the disease type is one of: Primary open angle glaucoma (POAG); Chronic angle closure glaucoma (CACG) where the eye is pseudophakic and a laser iridotomy has previously been performed; Pigmentary open angle glaucoma; Exfoliation open angle glaucoma; Rubeotic glaucoma that is treated and regressed/quiescent; Steroid-induced glaucoma; or Juvenile open angle glaucoma (JOAG). 2. There has been failure of previous treatment for glaucoma (it is 'refractory'), meeting ONE of the following requirements: i. Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy. ii. Failure of previous glaucoma surgery (not more than one operation) with trabeculectomy, Xen/PreserFlo, non-penetrating glaucoma surgery, a previously removed suprachoroidal drainage device, trabecular bypass (using iStents or Hydrus), or cilioablation. c. The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg. d. The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery. Key Exclusion Criteria: in the study eye: 1. Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator. 2. 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. 3. 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. 4. 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. 5. Central corneal endothelial cell density less than specified age-related thresholds at screening. 6. Intraocular silicone oil. 7. Significant corneal, retinal, inflammatory or infective ophthalmic pathology (full details specified in the protocol).
Where this trial is running
Sydney, New South Wales and 5 other locations
- Sydney Eye Hospital — Sydney, New South Wales, Australia (RECRUITING)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (RECRUITING)
- Cataract & Eye Surgery Centre — Doncaster East, Victoria, Australia (RECRUITING)
- Cerulea Clinical Trials, Centre for Eye Research Australia — East Melbourne, Victoria, Australia (RECRUITING)
- Melbourne Eye Specialists — Fitzroy, Victoria, Australia (RECRUITING)
- Eye Surgery Associates — Vermont South, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: Michael Coote — Melbourne Eye Specialists
- Study coordinator: Andrew Batty
- Email: contact@vividwhite.com.au
- Phone: +61 418 213 895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glaucoma