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

NCT06964061 | Active Not Recruiting Phase 1

• 1 other identifier: LATA-CS104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Open Angle Glaucoma (OAG); Ocular Hypertension (OH)

Outcome Measures

Primary Outcomes (2)

• 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

  Ocular safety and tolerability (AEs)

  Day 1 through study completion at least until Week 52

Secondary Outcomes (1)

• Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.

  Weeks 2-52

Other Outcomes (1)

• Time to complete biodegradation of the implant assessed by gonioscopy

  Day 1 through study completion at least until Week 52

Study Arms (1)

PA5436 Ocular Implant, 115mcg

EXPERIMENTAL

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

Combination Product: PA5436 Ocular Implant, 115mcg

Interventions

PA5436 Ocular Implant, 115mcg COMBINATION_PRODUCT

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

PA5436 Ocular Implant, 115mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent and follow study instructions
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PolyActiva Pty Ltd: lead

Study Sites (3)

Cataract & Eye Surgery Centre

Doncaster, Victoria, 3109, Australia

Location

Cerulea Pty Ltd

East Melbourne, Victoria, 3002, Australia

Location

Melbourne Eye Specialists

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 9, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)