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

Phase 1

Not yet recruiting

• Conditions: Open Angle Glaucoma (OAG); Ocular Hypertension (OH)

• Registration Number: NCT06964061
• Lead Sponsor: PolyActiva Pty Ltd

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.

Study Timeline

• Study First Submitted: 2025-03-18
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-05-15
• Primary Completion: 2026-11-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy: change in mean diurnal intraocular pressure in study eye	Weeks 2, 12, 26 and 52
Incidence of ocular symptoms and ocular treatment-emergent adverse events	Day 1 through study completion at least until Week 52	Ocular safety and tolerability (AEs)

Secondary Outcome Measures

Name	Time	Method
Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.	Weeks 2-52