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Virus Therapy
PER-001 for Diabetic Retinopathy
Phase 2
Waitlist Available
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
Must not have
Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture
Uncontrolled atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study(week 24)
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a specific eye condition affecting my retina or macula.
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I have atrial fibrillation that is not well-managed.
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I have or had eye inflammation due to an autoimmune condition.
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I have had repeated eye infections or inflammation.
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My eye condition affects the central part of my retina.
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I have had my natural lens removed or lack the back part of the lens capsule.
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My eye pressure is below 25 mmHg.
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I have active rubeosis.
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I have had eye surgery for a detached retina or a severe macular hole.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best-corrected Visual Acuity (BCVA)
Intraocular Pressure (IOP)
Ocular Adverse events
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Perfuse Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled