PER-001 Intravitreal Implant for Open-Angle Glaucoma

Not currently recruiting at 1 trial location

Overseen By Andrew Melie

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Perfuse Therapeutics, Inc.

Disqualifiers: Hypertension, Hypotension, Dementia, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called PER-001, an intravitreal implant, for individuals with open-angle glaucoma. This condition blocks the eye's drainage system, leading to vision loss. The study consists of two phases: the first tests different doses of the treatment, and the second compares it to a sham (placebo). Individuals diagnosed with advanced or progressing open-angle glaucoma and possessing specific vision capabilities may qualify. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not have a change in eye pressure-lowering therapy within 6 weeks before the trial and during the study.

Is there any evidence suggesting that PER-001 is likely to be safe for humans?

Research shows that PER-001, a small device placed in the eye to treat open-angle glaucoma, is generally safe and well-tolerated. In earlier studies, data from 24 weeks showed that the treatment was safe, with only two drug-related side effects reported. These side effects were not serious and did not raise major safety concerns. This suggests that PER-001 is promising in terms of safety for those considering participation in a clinical trial. ^{1 2 3 4 5}

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

Unlike the standard glaucoma treatments like eye drops, laser therapy, or surgery, the PER-001 treatment introduces a unique approach by using an intravitreal implant. This implant delivers medication directly into the eye, potentially offering a more continuous and consistent release of medication, which could improve patient adherence and efficacy. Researchers are excited about this because it could mean fewer side effects and a more effective lowering of intraocular pressure, which is crucial for preserving vision in patients with open-angle glaucoma.

What evidence suggests that the PER-001 intravitreal implant could be an effective treatment for open-angle glaucoma?

Research shows that the PER-001 eye implant has promising results for people with open-angle glaucoma. In this trial, participants will join different cohorts to receive either a high or low dose of PER-001, or a sham treatment. A previous study found that patients who received a single dose of PER-001 experienced better vision and healthier eye structure compared to those who did not receive the treatment. Users of PER-001 noticed improved vision, with a positive change in their visual field by about 1.1 to 1.5 decibels per year. This suggests that the treatment could help slow down vision loss caused by glaucoma. PER-001 works by blocking certain proteins that can damage vision, thereby protecting the eyes. These early findings offer hope for better treatment options for those with open-angle glaucoma. ^{1 2 3 5 6}

Who Is on the Research Team?

Phillip Lai, MD

Principal Investigator

Perfuse Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or severe primary open-angle glaucoma (OAG), including normal tension, pseudoexfoliation, and pigment dispersion. Participants must have an intraocular pressure (IOP) of 6-25 mmHg and a visual acuity score indicating they can see well enough to participate. Pregnant women or those planning pregnancy are excluded, as are individuals with certain eye conditions or recent eye surgeries.

Inclusion Criteria

My primary open-angle glaucoma is getting worse in the study eye.

My eye pressure is between 6 and 25 mmHg.

My vision, with correction, is good enough in at least one eye.

Exclusion Criteria

I haven't changed my eye pressure treatment in the last 6 weeks and don't plan to change it during the study.

I do not have any active severe eye infections.

Any significant media opacity which precludes clinical evaluation and imaging of the retina

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Open-label, single ascending dose study to investigate safety and tolerability of two dose levels of PER-001 in participants with advanced OAG

12 weeks

Phase 2a Treatment

Randomized, single-masked study to investigate safety and tolerability of two dose levels of PER-001 Intravitreal Implants in participants with progressing glaucoma

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PER-001

Trial Overview The study tests PER-001 Intravitreal Implant at different doses compared to a sham procedure in two phases: Phase 1 where all receive the implant at increasing doses, and Phase 2a which is randomized and single-masked meaning participants don't know if they're getting the real treatment or a sham.

How Is the Trial Designed?

Group I: Phase 2 Cohort D Experimental Treatment 2 Interventions

Cohort D - High Dose or Sham

Group II: Phase 2 Cohort C Experimental Treatment 2 Interventions

Cohort C - Low Dose or Sham

Group III: Phase 1 Cohort B Experimental Treatment 1 Intervention

Cohort B - High Dose

Group IV: Phase 1 Cohort A Experimental Treatment 1 Intervention

Cohort A - Low Dose

Who Is Running the Clinical Trial?

Perfuse Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

In a study involving 35 eyes from 34 patients with severe glaucoma, a new technique using a Baerveldt implant with a titrated absorbable ligature effectively reduced intraocular pressure (IOP) from a mean of 42.8 mm Hg preoperatively to a final mean of 13.8 mm Hg after an average follow-up of 13 months, representing a 67.8% reduction.

The technique resulted in a high success rate, with 82.9% of eyes achieving complete success in IOP control, although some complications like choroidal detachments and transient tube obstructions were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. Ortiz Arismendi, GE., Peña Valderrama, Cdel P., Albis-Donado, O.[2022]

The 350-mm2 Baerveldt glaucoma implant demonstrated a higher overall success rate of 87% in controlling intraocular pressure (IOP) compared to 70% for the 500-mm2 implant over an average follow-up of 37 months.

Both implants showed similar rates of visual acuity improvement and complications, indicating that while the 350-mm2 implant is more effective for IOP control, both options are comparably safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Britt, MT., LaBree, LD., Lloyd, MA., et al.[2022]

Citations

1. perfusetherapeutics.com perfusetherapeutics.com/perfuse-therapeutics-announces-positive-results-from-the-completed-phase-1-2a-clinical-trial-of-per-001-intravitreal-implant-in-patients-with-glaucoma/

A single intravitreal administration of PER-001 improved ... A single intravitreal administration of PER-001 improved both visual function and anatomic structure compared to control at 24 weeks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05822245

NCT05822245 | A Study of PER-001 in Participants With ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

3. prnewswire.com prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-results-from-the-completed-phase-12a-clinical-trial-of-per-001-intravitreal-implant-in-patients-with-glaucoma-302446082.html

Perfuse Therapeutics Announces Positive Results from the ... Patients treated with PER-001 showed improved vision; the improvement in VF mean deviation from baseline was +1.5 and +1.1 decibel (dB) per year ...

4. clinicalleader.com clinicalleader.com/doc/the-future-of-glaucoma-therapy-adaptive-trial-design-and-patient-centric-protocols-0001

The Future of Glaucoma Therapy Adaptive Trial Design ... But recently, Perfuse Therapeutics unveiled promising 24-week data from its Phase 1/2a trial of PER-001, a first-in-class endothelin antagonist ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05822245?term=A%20Study%20of%20PER-001%20in%20Participants%20With%20Open-Angle%20Glaucoma&rank=1

A Study of PER-001 in Participants With Open-Angle ... Phase 2a is a randomized, single-masked (participant) study to further investigate the ocular and systemic safety and tolerability of the two dose levels of PER ...

6. withpower.com withpower.com/trial/phase-2-glaucoma-3-2023-fe802

PER-001 Intravitreal Implant for Open-Angle Glaucoma The safety of various glaucoma implants, like the XEN45 and Ahmed valve, has been studied, showing they are generally safe for reducing eye pressure in glaucoma ...