VW-50 Feasibility Study

NCT07730424 | Completed

• 1 other identifier: DF-450
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Primary feasibility outcome

  Assessment of the ease of implantation of VW-50 in the human eye, measured by surgeon questionnaire assessment of implantation technique (custom 11-item questionnaire with 5 responses selectable per item, ranging from 'strongly disagree' to 'strongly agree')

  At study intervention

Secondary Outcomes (8)

• Secondary feasibility outcome 1

  At study intervention

• Secondary feasibility outcome 2

  12 months

• Safety and tolerability outcome 1

  12 months

• Safety and tolerability outcome 2

  12 months

• Safety and tolerability outcome 3

  12 months

Study Arms (1)

VW-50

EXPERIMENTAL

VW-50 glaucoma implant

Device: Surgical implantation of VW-50

Interventions

Surgical implantation of VW-50 DEVICE

Implantation of VW-50 (alone or in combination with cataract surgery)

VW-50

Eligibility Criteria

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

You may qualify if:

• Age - greater than 18 years of age.
• Glaucoma - as diagnosed by the investigator based upon untreated intraocular pressure, disc appearance, and visual field abnormalities.
• Failed medical treatment - In the opinion of the investigator, the IOP is uncontrolled in the study eye after having failed previous medical treatment.
• Conjunctival health - In the opinion of the investigator the participant should have a healthy, free, and mobile conjunctiva in the target quadrant.
• Capable - Ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.

You may not qualify if:

• Prior glaucoma surgery in the study eye.
• Advanced glaucomatous optic nerve damage which, in the opinion of the investigator, threatens fixation and/or standard surgery would be considered safer.
• Active neovascular glaucoma, Iridocorneal Endothelial (ICE) Syndrome, traumatic glaucoma, silicone oil induced glaucoma, active acute angle closure glaucoma or subluxation of the lens.
• Active diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy, or other ophthalmic disease or disorder in the study eye that could confound study results.
• Any condition of the cornea that could confound study results or would preclude accurate readings with an applanation tonometer and/or a contact pachymeter.
• Visually significant cataract in the study eye that will not be removed at the time of implantation.
• BCVA worse than 6/30 (Snellen equivalent)
• Clinically significant inflammation or infection in either eye
• Unfit for local anaesthetic surgery.
• Any uncontrolled systemic disease.
• Female participants who are pregnant, nursing, or planning a pregnancy during the study, or who are of childbearing potential and not using a reliable means of contraception during the study.
• Significant risk of bleeding.

Sponsors & Collaborators

• Melbourne Eye Specialists: lead

Study Sites (1)

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 28, 2026
• Study Start: August 4, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)