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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06176170




Registration number
NCT06176170
Ethics application status
Date submitted
10/12/2023
Date registered
19/12/2023

Titles & IDs
Public title
VividWhite Glaucoma Implant (VW-51) Pivotal Study
Scientific title
A Prospective Multicentre Pivotal Clinical Study to Demonstrate the Efficacy and Safety of the VividWhite Glaucoma Implant (VW-51) for the Treatment of Glaucoma.
Secondary ID [1] 0 0
DF-550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VividWhite Glaucoma Implant (VW-51)

Experimental: VividWhite Glaucoma Implant (VW-51) - Surgical implantation of VW-51.


Treatment: Devices: VividWhite Glaucoma Implant (VW-51)
Subconjunctival surgical implantation of the VW-51 implant in the study eye.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete success by efficacy and safety criteria
Timepoint [1] 0 0
Study completion (12 months)

Eligibility
Key inclusion criteria
Key Glaucoma in the study eye, meeting the following requirements:

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.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
in the study eye:

1. Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
2. 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.
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Cataract & Eye Surgery Centre - Doncaster East
Recruitment hospital [4] 0 0
Cerulea Clinical Trials, Centre for Eye Research Australia - East Melbourne
Recruitment hospital [5] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [6] 0 0
Eye Surgery Associates - Vermont South
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3109 - Doncaster East
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3133 - Vermont South

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
VividWhite Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Coote
Address 0 0
Melbourne Eye Specialists
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Batty
Address 0 0
Country 0 0
Phone 0 0
+61 418 213 895
Fax 0 0
Email 0 0
contact@vividwhite.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06176170