PER-001 for Diabetic Retinopathy

Overseen By Andrew Melie

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Perfuse Therapeutics, Inc.

Must not be taking: Systemic anti-VEGF

Disqualifiers: Uncontrolled diabetes, Active cancer, 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: 24 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic anti-VEGF treatment, you must have stopped it at least 4 months before starting the trial.

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.

Women who could become pregnant must have a negative pregnancy test before starting the study.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of PER-001 Intravitreal Implant or sham control

24 weeks

Multiple visits for monitoring

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 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.

Participant Groups

Group I: Phase 2 Cohort B Experimental Treatment 2 Interventions

Cohort B - High Dose or Sham

Group II: Phase 2 Cohort A Experimental Treatment 2 Interventions

Cohort A - Low Dose or Sham

Who Is Running the Clinical Trial?

Perfuse Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

60+