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Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT06964061

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-11-15

Brief Summary

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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

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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.

Conditions

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Open Angle Glaucoma (OAG) Ocular Hypertension (OH)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PA5436 Ocular Implant, 115mcg

PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection

Group Type EXPERIMENTAL

PA5436 Ocular Implant, 115mcg

Intervention Type COMBINATION_PRODUCT

The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.

Interventions

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PA5436 Ocular Implant, 115mcg

The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PolyActiva Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cataract & Eye Surgery Centre

Doncaster, Victoria, Australia

Site Status RECRUITING

Cerulea Pty Ltd

East Melbourne, Victoria, Australia

Site Status RECRUITING

Melbourne Eye Specialists

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Vanessa Waddell

Role: CONTACT

Phone: +61 3 90203565

Email: [email protected]

Facility Contacts

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Marios Constantinou

Role: primary

Other Identifiers

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LATA-CS104

Identifier Type: -

Identifier Source: org_study_id