Clinical trial NCT06964061: Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: An Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Biodegradation Period of PA5346 Ocular Implant, 115mcg When Administered to Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Open Angle Glaucoma (OAG)
Ocular Hypertension (OH)
Lead sponsor: PolyActiva Pty Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 12
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 goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.

Detailed description: This is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of PA5346 Ocular Implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension.

The study plans to recruit approximately 12 participants. Eligible participants will receive a single PA5346 Ocular Implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.

Eligibility criteria: Key Inclusion Criteria:

* Ability to provide informed consent and follow study instructions
* 18 years of age or older
* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
* Qualifying corneal endothelial cell density (CEDC) in the study eye

Key Exclusion Criteria:

* Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
* Advanced or severe glaucoma
* Disqualifying central corneal thickness in either eye
* Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
* Uncontrolled medical conditions
* Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
* Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
* Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days

Primary outcomes:
measure: Efficacy: change in mean diurnal intraocular pressure in study eye
timeFrame: Weeks 2, 12, 26 and 52
measure: Incidence of ocular symptoms and ocular treatment-emergent adverse events
timeFrame: Day 1 through study completion at least until Week 52
Secondary outcomes:
measure: Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.
timeFrame: Weeks 2-52
Other outcomes:
measure: Time to complete biodegradation of the implant assessed by gonioscopy
timeFrame: Day 1 through study completion at least until Week 52
Locations:
city: Doncaster
country: Australia
facility: Cataract & Eye Surgery Centre
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne Eye Specialists
state: Victoria
Study officials:
References: