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A Study of PER-001 in Participants With Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PER-001 Intravitreal Implant - Low Dose
PER-001 Intravitreal Implant - High Dose
PER-001 Intravitreal Implant - Sham
Sponsored by
Perfuse Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 >160 or diastolic >95 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

Sites / Locations

  • Perfuse Therapeutics, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 2 Cohort A

Phase 2 Cohort B

Arm Description

Cohort A - Low Dose or Sham

Cohort B - High Dose or Sham

Outcomes

Primary Outcome Measures

Best-corrected Visual Acuity (BCVA)
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
Intraocular Pressure (IOP)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
Ocular Adverse events
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
Systemic Adverse events
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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
August 22, 2023
Sponsor
Perfuse Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06003751
Brief Title
A Study of PER-001 in Participants With Diabetic Retinopathy
Official Title
A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perfuse Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Masking Description
Placebo sham
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Cohort A
Arm Type
Experimental
Arm Description
Cohort A - Low Dose or Sham
Arm Title
Phase 2 Cohort B
Arm Type
Experimental
Arm Description
Cohort B - High Dose or Sham
Intervention Type
Drug
Intervention Name(s)
PER-001 Intravitreal Implant - Low Dose
Intervention Description
PER-001 Low Dose Intravitreal Implant
Intervention Type
Drug
Intervention Name(s)
PER-001 Intravitreal Implant - High Dose
Intervention Description
PER-001 High Dose Intravitreal Implant
Intervention Type
Drug
Intervention Name(s)
PER-001 Intravitreal Implant - Sham
Intervention Description
PER-001 Intravitreal Sham
Primary Outcome Measure Information:
Title
Best-corrected Visual Acuity (BCVA)
Description
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
Time Frame
End of Study(Week 24)
Title
Intraocular Pressure (IOP)
Description
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
Time Frame
End of Study(Week 24)
Title
Ocular Adverse events
Description
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
Time Frame
End of Study(Week 24)
Title
Systemic Adverse events
Description
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
Time Frame
End of Study(Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 >160 or diastolic >95 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Melie
Phone
415-294-8750
Email
info@perfusetherapeutics.com
Facility Information:
Facility Name
Perfuse Therapeutics, Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Melie
Phone
415-294-8750
Email
info@perfusetherapeutics.com

12. IPD Sharing Statement

Learn more about this trial

A Study of PER-001 in Participants With Diabetic Retinopathy

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