PA5108 ocular implants to lower eye pressure in open-angle glaucoma or ocular hypertension
A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
We will test whether low- or high-dose PA5108 eye implants lower eye pressure more than standard Latanoprost drops in adults with open-angle glaucoma or ocular hypertension.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | PolyActiva Pty Ltd Industry-sponsored |
| Locations | 1 site (Newport Beach, California) |
| Trial ID | NCT06964191 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized, parallel, masked, active-controlled study compares low- and high-dose PA5108 ocular implants against Latanoprost 0.005% eye drops in adults with open-angle glaucoma or ocular hypertension. About 75 participants will be randomly assigned to receive a low-dose implant (with Latanoprost in the fellow eye), a high-dose implant (with Latanoprost in the fellow eye), or Latanoprost drops in both eyes as the control. Implant recipients will receive a second identical implant at week 26 and will be followed through week 58 or until the implant is no longer visible to monitor intraocular pressure and safety. The study will also record details of the implant administration procedure and participants' experiences with the implant.
Who should consider this trial
Good fit: Adults 18 or older with bilateral open-angle glaucoma or ocular hypertension who meet the study's intraocular pressure, visual acuity, and corneal endothelial cell density criteria and can attend regular follow-up visits are ideal candidates.
Not a fit: Patients with narrow angles, pseudoexfoliation or pigment dispersion, advanced or severe glaucoma, disqualifying corneal measurements, significant other ocular disease, prior anterior chamber injectable glaucoma treatments, or uncontrolled medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, PA5108 implants could provide longer-lasting intraocular pressure control and reduce the need for daily eye drops.
How similar studies have performed: Other intracameral sustained-release ocular implants (for example, bimatoprost implants) have shown intraocular pressure lowering in prior studies, so the general approach has clinical precedent although PA5108 itself is distinct.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newport Beach, California
- Eye Research Foundation — Newport Beach, California, United States (Recruiting)
Study contacts
- Study coordinator: Vanessa Waddell
- Email: vanessa.waddell@polyactiva.com
- Phone: +61 3 9020 3565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.