Status:
ACTIVE_NOT_RECRUITING
VividWhite Glaucoma Implant (VW-51) Pivotal Study
Lead Sponsor:
VividWhite Pty Ltd
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 effe...
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 a...
Eligibility Criteria
Inclusion
- Key Glaucoma in the study eye, meeting the following requirements:
- 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).
- 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
- in the study eye:
- 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).
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06176170
Start Date
December 12 2023
End Date
December 1 2026
Last Update
November 18 2025
Active Locations (6)
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1
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
2
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
3
Cataract & Eye Surgery Centre
Doncaster East, Victoria, Australia, 3109
4
Cerulea Clinical Trials, Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002