Clinical trial NCT06176170: VividWhite Glaucoma Implant (VW-51) Pivotal Study
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: VividWhite Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria: 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 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).

Primary outcomes:
measure: Complete success by efficacy and safety criteria
timeFrame: Study completion (12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Doncaster East
country: Australia
facility: Cataract & Eye Surgery Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Cerulea Clinical Trials, Centre for Eye Research Australia
state: Victoria
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists
state: Victoria
city: Vermont South
country: Australia
facility: Eye Surgery Associates
state: Victoria
Study officials:
affiliation: Melbourne Eye Specialists
name: Michael Coote
role: PRINCIPAL_INVESTIGATOR
References: