VividWhite Glaucoma Implant (VW-51) Pivotal Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VividWhite Glaucoma Implant (VW-51)

Surgical implantation of VW-51.

Group Type EXPERIMENTAL

VividWhite Glaucoma Implant (VW-51)

Intervention Type DEVICE

Subconjunctival surgical implantation of the VW-51 implant in the study eye.

Interventions

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VividWhite Glaucoma Implant (VW-51)

Subconjunctival surgical implantation of the VW-51 implant in the study eye.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

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).