PER-001 Intravitreal Implant for Open-Angle Glaucoma

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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, single ascending dose (SAD), while Phase 2a is a randomized, single-masked (participant) with a sham control.

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.

What data supports the effectiveness of the treatment PER-001 for open-angle glaucoma?

The research on the Xen® implant, which is another type of implant used for open-angle glaucoma, shows that it is safe and effective in real-life conditions. This suggests that similar implant treatments like PER-001 might also be effective for this condition. ^{1 2 3 4 5}

What safety data exists for the 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 patients. However, specific safety data for the PER-001 implant is not available in the provided research articles. ^{3 4 6 7 8}

How is the PER-001 treatment for open-angle glaucoma different from other treatments?

The PER-001 treatment is unique because it involves an intravitreal implant, which means it is placed directly into the eye, potentially offering a more targeted and sustained release of medication compared to other treatments that might require more frequent administration or different surgical techniques. ^{2 4 9 10 11}

Research Team

Phillip Lai, MD

Principal Investigator

Perfuse Therapeutics, Inc.

Eligibility Criteria

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.

Blood pressure >140/90 mmHg or <90/60 mmHg at Screening

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sequential glaucoma implants in refractory glaucoma. [2010]

2. India pubmed.ncbi.nlm.nih.gov

Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Managing high risk glaucoma with the Ahmed valve implant: 20 years of experience. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Gelatin implant in the treatment of open-angle glaucoma: Safety and efficacy in real-life conditions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Otago glaucoma surgery outcome study: comparative results for the 175-mm2 Molteno3 and double-plate molteno implants. [2013]

6. England pubmed.ncbi.nlm.nih.gov

One-year result of XEN45 implant for glaucoma: efficacy, safety, and postoperative management. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinicopathologic correlations of poly-(styrene-b-isobutylene-b-styrene) glaucoma drainage devices of different internal diameters in rabbits. [2011]

8. India pubmed.ncbi.nlm.nih.gov

Self-engineered Acry C plants in nonpenetrating glaucoma surgery. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical results with the Trabectome for treatment of open-angle glaucoma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Optical coherence tomography of the Ex-PRESS miniature glaucoma implant. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? [2022]