PER-001 for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Perfuse Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.

Eligibility Criteria

This trial is for adults over 18 with moderate to severe non-proliferative diabetic retinopathy, vision of 20/63 or better, and no recent serious health issues like cancer or heart attack. Pregnant women and those with uncontrolled diabetes, blood pressure, eye infections/inflammation, glaucoma, or a history of certain eye surgeries are excluded.

Inclusion Criteria

My diabetic eye condition is moderately severe to severe.

My vision is 20/63 or better with correction in the eye(s) that may be in the study.

I am 18 years old or older.

+1 more

Exclusion Criteria

I had cataract surgery or YAG procedure recently.

I have a specific eye condition affecting my retina or macula.

I have atrial fibrillation that is not well-managed.

+18 more

Participant Groups

The study tests PER-001 Intravitreal Implant at two different doses against a sham procedure in people with diabetic retinopathy. It's randomized and single-masked meaning participants don't know if they're getting the real treatment or the sham.

2Treatment groups

Experimental Treatment

Group I: Phase 2 Cohort BExperimental Treatment2 Interventions

Cohort B - High Dose or Sham

Group II: Phase 2 Cohort AExperimental Treatment2 Interventions

Cohort A - Low Dose or Sham