PA5108 Ocular Implants for Glaucoma

Overseen By Vanessa Waddell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: PolyActiva Pty Ltd

Disqualifiers: Advanced glaucoma, Uncontrolled conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 58 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an ocular implant called PA5108 to determine the optimal dose for lowering eye pressure in individuals with open-angle glaucoma or ocular hypertension. It compares high and low doses of the implant to the standard eye drop treatment, latanoprost. Individuals diagnosed with open-angle glaucoma or ocular hypertension in both eyes, who do not use contact lenses, might be suitable candidates. The study aims to assess whether the implant can safely and effectively reduce eye pressure more than current treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in eye care.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for IOP-lowering medications, if applicable. This means you may need to stop taking these specific medications before participating.

What prior data suggests that the PA5108 Ocular Implant is safe for reducing intraocular pressure?

Research has shown that the PA5108 Ocular Implant is safe and generally well tolerated. Studies have found no negative effects on the corneal endothelium, the inner layer of the eye's clear front part. The implant met safety goals in earlier tests, indicating it did not harm users. For those considering joining a trial for this treatment, current evidence suggests it maintains a good safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about the PA5108 Ocular Implants for glaucoma because they offer a new approach to treating this eye condition. Unlike standard treatments like eye drops that must be applied daily, the PA5108 Ocular Implant provides a longer-lasting solution by being implanted directly into the eye. This not only reduces the need for daily medication but also ensures a consistent delivery of the drug. Additionally, the implants come in high and low doses, potentially offering personalized treatment options based on the severity of the condition. This innovative delivery method could significantly improve the quality of life for patients by simplifying their treatment routine and ensuring better management of intraocular pressure.

What evidence suggests that the PA5108 Ocular Implant is effective for reducing intraocular pressure in glaucoma?

Research has shown that the PA5108 Ocular Implant is a promising treatment for glaucoma. In this trial, participants will receive either a high dose or a low dose of the PA5108 Ocular Implant in one eye, while the other eye receives latanoprost ophthalmic solution. Studies have found that the implant can lower eye pressure by more than 20%, which is crucial for managing glaucoma. This reduction is significant and could greatly improve patient outcomes. The implant works by slowly releasing medication directly into the eye, helping to maintain consistently low eye pressure. Early results suggest it is both effective and safe, making it an exciting option for individuals with open-angle glaucoma or high eye pressure. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with open-angle glaucoma or ocular hypertension in both eyes. Participants must have a certain level of corneal cells, be able to consent and follow instructions, have specific intraocular pressure after stopping other IOP medications if needed, and meet vision acuity standards.

Inclusion Criteria

I have been diagnosed with open-angle glaucoma or high eye pressure in both eyes.

I can understand and agree to the study's requirements.

My eye pressure readings are stable after stopping any eye pressure medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PA5108 Ocular Implant or Latanoprost eye drops, with a second implant administered at 26 weeks

58 weeks

Regular visits for monitoring and administration

Follow-up

Participants are monitored for safety and intraocular pressure control after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PA5108 Ocular Implant

Trial Overview The study tests the effectiveness and safety of PA5108 Ocular Implant at high and low doses versus standard Latanoprost eye drops in reducing eye pressure for patients with primary open-angle glaucoma or ocular hypertension.

How Is the Trial Designed?

Group I: PA5108 Ocular Implant low dose Experimental Treatment 2 Interventions

PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.

Group II: PA5108 Ocular Implant high dose Experimental Treatment 2 Interventions

PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.

Group III: Latanoprost ophthalmic solution 0.005% Active Control 1 Intervention

Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.

Who Is Running the Clinical Trial?

PolyActiva Pty Ltd

Lead Sponsor

Trials

5

Recruited

50+

IUVO S.r.l.

Industry Sponsor

Trials

1

Recruited

20+

Citations

1. ophthalmologytimes.com ophthalmologytimes.com/view/polyactiva-s-pa5108-glaucoma-implant-shows-promising-results-in-clinical-trial-paving-the-way-for-long-term-drug-delivery

PolyActiva's PA5108 glaucoma implant shows promising ... PolyActiva's phase 2 clinical trial of its PA5108 glaucoma implant met efficacy and safety end points, demonstrating more than 20% reduction in IOP.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06964191

Evaluate Efficacy and Safety of PA5108 Ocular Implants in ... The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult ...

3. glaucoma.org.au glaucoma.org.au/news-details/research/glaucoma-implant-positive-trial-data

Glaucoma Implant Positive Trial Data Seventeen participants were recruited to receive two PA5108 ocular implants, 21 weeks apart and at the time of the data being released, 15 participants had ...

4. polyactiva.com polyactiva.com/wp-content/uploads/2022/03/170222.pdf

170222.pdf “The results of the low dose cohort demonstrate that the implant achieves a clinically meaningful IOP-lowering effect,” commented Associate ...

5. meded.co.za meded.co.za/DocumentPart/?id=7451

Novel Ocular Implant for Glaucoma Treatment Shows ... The Phase 2a trial of PA5108, a novel glaucoma treatment implant, demonstrated statistically significant reductions in intraocular pressure, ...

6. glaucomatoday.com glaucomatoday.com/articles/2024-nov-dec/new-solutions-for-sustained-drug-delivery

New Solutions for Sustained Drug Delivery PA5108 is designed to be implanted in an in- office procedure. PolyActiva recently announced that the implant met safety and efficacy endpoints ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04060758

NCT04060758 | Open Label, Sequential-dose Study of ... This is a multi-centre, open label, interventional, comparative, phase I study to identify a safe and efficacious dose (within the range of 14.7mcg to 35.5 ...