- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176170
VividWhite Glaucoma Implant (VW-51) Pivotal Study
A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Batty
- Phone Number: +61 418 213 895
- Email: contact@vividwhite.com.au
Study Locations
-
-
Victoria
-
Fitzroy, Victoria, Australia, 3065
- Recruiting
- Melbourne Eye Specialists
-
Contact:
- Michael Coote
- Phone Number: +61 3 9417 1055
- Email: reception@melbeye.com.au
-
Principal Investigator:
- Michael Coote
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria: 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 Criteria: 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VividWhite Glaucoma Implant (VW-51)
Surgical implantation of VW-51.
|
Subconjunctival surgical implantation of the VW-51 implant in the study eye.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete success by efficacy and safety criteria
Time Frame: Study completion (12 months)
|
Efficacy Criteria:
|
Study completion (12 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Coote, Melbourne Eye Specialists
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF-550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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