PER-001 Intravitreal Implant for Open-Angle Glaucoma

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Perfuse Therapeutics, Inc.

No Placebo Group

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.

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

Treatment Details

Interventions

• PER-001 (Other)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MidWest Eye Institute Indianapolis, IN

Perfuse Therapeutics, Inc. San Francisco, CA

Who Is Running the Clinical Trial?

Perfuse Therapeutics, Inc.

Lead Sponsor

Trials

2

Patients Recruited

60+