VividWhite Glaucoma Implant (VW-51) Pivotal Study

NCT06176170 | Active Not Recruiting DMC

• 1 other identifier: DF-550
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

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 effectiveness of the VW-51 implant.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

VividWhite Glaucoma Implant (VW-51)

EXPERIMENTAL

Surgical implantation of VW-51.

Device: VividWhite Glaucoma Implant (VW-51)

Interventions

VividWhite Glaucoma Implant (VW-51) DEVICE

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

VividWhite Glaucoma Implant (VW-51)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
• 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).

Sponsors & Collaborators

• VividWhite Pty Ltd: lead

Study Sites (6)

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Cataract & Eye Surgery Centre

Doncaster East, Victoria, 3109, Australia

Location

Cerulea Clinical Trials, Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

Eye Surgery Associates

Vermont South, Victoria, 3133, Australia

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Michael Coote

  Melbourne Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)