A Study of PER-001 in Participants With Diabetic Retinopathy

April 10, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Perfuse Therapeutics, Inc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Perfuse Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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