A Study of PER-001 in Participants With Diabetic Retinopathy

November 13, 2023 updated by: Perfuse Therapeutics, Inc.

A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy

This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study is a randomized, single-masked (participant) study to further investigate the ocular and systemic safety and tolerability of the two dose levels of PER-001 Intravitreal Implants in participants with diabetic retinopathy. Participants who meet entry criteria will be randomized to receive either dose of PER-001 or sham control. A total of approximately 24 participants (12 in each Cohort, will be randomized).

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must be ≥ 18 years of age at the time of signing the informed consent
  • A negative pregnancy test for females of childbearing potential at Screening (serum) and Day 1 (urine).
  • 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
  • Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (diabetic retinopathy severity scale [DRSS] of 47 to 53) within the standard 7-field ETDRS.

Exclusion Criteria:

  • Hemoglobin A1c >12%, or if HbA1c ≤12%, diabetes mellitus is uncontrolled in the opinion of the investigator
  • Any condition which, in the opinion of the investigator, would preclude the participant's ability to comply with study requirements including completion of the study (including but not limited to diagnosis of dementia, Alzheimer's, and/or other neurological disease or physical incapacity)
  • Females who are pregnant, nursing, or planning a pregnancy during the study
  • Active cancer within past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma or prostate cancer
  • Uncontrolled blood pressure (defined as systolic >180 or diastolic >110 mmHg while the participant is sitting).
  • Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
  • History of cerebrovascular accident or myocardial infarction within 6 months prior to Day 1
  • Uncontrolled atrial fibrillation
  • Systemic anti-VEGF treatment within 4 months prior to Day 1
  • Any significant media opacity which precludes clinical evaluation and imaging of the retina
  • Presence of centrally involved DME (within 500 μm of the foveal center) at Screening and Day 1
  • Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture
  • Active rubeosis
  • History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)
  • Uncomplicated cataract surgery within 3 months of Screening or yttrium-aluminum- garnet capsulotomy (YAG) within 4 weeks of Screening
  • Aphakia or absence of posterior capsule
  • Evidence of uncontrolled glaucoma (intraocular pressure must be < 25 mmHg) at Screening
  • History of recurrent infectious or inflammatory ocular disease
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild blepharitis is permitted if stable)
  • Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated uveitis
  • History of herpetic ocular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2 Cohort A
Cohort A - Low Dose or Sham
Drug: PER-001 Intravitreal Implant - Low Dose
PER-001 Low Dose Intravitreal Implant
Drug: PER-001 Intravitreal Implant - Sham
PER-001 Intravitreal Sham
Experimental: Phase 2 Cohort B
Cohort B - High Dose or Sham
Drug: PER-001 Intravitreal Implant - High Dose
PER-001 High Dose Intravitreal Implant
Drug: PER-001 Intravitreal Implant - Sham
PER-001 Intravitreal Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected Visual Acuity (BCVA)
Time Frame: End of Study(Week 24)
Change in BCVA from Baseline at Week 24 using BETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting ill be used to calculate the LogMAR score
End of Study(Week 24)
Intraocular Pressure (IOP)
Time Frame: End of Study(Week 24)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
End of Study(Week 24)
Ocular Adverse events
Time Frame: End of Study(Week 24)
Frequency, severity and timing of ocular adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
End of Study(Week 24)
Systemic Adverse events
Time Frame: End of Study(Week 24)
Frequency, severity and timing of systemic adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
End of Study(Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perfuse Therapeutics, Inc.

Investigators

  • Study Director: Phil Lai, MD, Perfuse Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER001-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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