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VividWhite Glaucoma Implant (VW-51) Pivotal Study

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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: Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy. 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.

The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg.

The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery.

Exclusion criteria

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-12-12

Primary completion: 2025-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

Trial ID

NCT06176170

Intervention or treatment

DEVICE: VividWhite Glaucoma Implant (VW-51)

Conditions

• Glaucoma

Condition: Glaucoma
DEVICE: VividWhite Glaucoma Implant (VW-51)
Bedford Park, South Australia, Australia and more
Sponsor: VividWhite Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Flinders Medical Centre

Research sites nearby

Select from list below to view details:

Flinders Medical Centre
Bedford Park, South Australia, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Cataract & Eye Surgery Centre
Doncaster East, Victoria, Australia
Cerulea Clinical Trials, Centre for Eye Research Australia
East Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: VividWhite Glaucoma Implant (VW-51) Surgical implantation of VW-51.	DEVICE: VividWhite Glaucoma Implant (VW-51) Subconjunctival surgical implantation of the VW-51 implant in the study eye.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Complete success by efficacy and safety criteria	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).	Study completion (12 months)

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: VividWhite Glaucoma Implant (VW-51) Pivotal Study