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Virus Therapy

PER-001 for Diabetic Retinopathy

Phase 2

Recruiting

Research Sponsored by Perfuse Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (diabetic retinopathy severity scale [DRSS] of 47 to 53) within the standard 7-field ETDRS

Best-corrected visual acuity (BCVA) of ≥ 60 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of 20/63 or better) at Screening in potentially eligible eye(s) and prior to randomization at Day 1 in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study(week 24)

Awards & highlights

Study Summary

This trial will test an experimental treatment to see if it is safe and effective for a medical condition.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, intravitreal implants can generally cause eye redness, discomfort or pain at the injection site, increased intraocular pressure, and potential infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diabetic eye condition is moderately severe to severe.

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study(week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study(week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study(week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best-corrected Visual Acuity (BCVA)

Intraocular Pressure (IOP)

Ocular Adverse events

+1 more

Trial Design

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Perfuse Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially endorsed Cohort A of Phase 2?

"Considering the fact that Phase 2 Cohort A is in its second clinical trial, there exists some safety data but none on efficacy. Thus, our team at Power gauged this drug's safety to be a score of 2."

Answered by AI

Are there opportunities for recruitment in this experiment?

"Absolutely. According to clinicaltrials.gov, this medical study first began recruitment on August 1st 2023 and was last revised on the 22nd of that month. It seeks 24 participants from a single site."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. It appears the trial, which was introduced on August 1st 2023 is still actively recruiting patients. 24 individuals are needed for this venture at a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of PER-001 in Participants With Diabetic Retinopathy

2023. "A Study of PER-001 in Participants With Diabetic Retinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003751.

All > Diabetic Retinopathy