A Study of PER-001 in Participants With Diabetic Retinopathy

NCT06003751 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PER001-202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (4)

• 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

  End of Study(Week 24)

• Intraocular Pressure (IOP)

  IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.

  End of Study(Week 24)

• 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

  End of Study(Week 24)

• 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

  End of Study(Week 24)

Study Arms (2)

Phase 2 Cohort A

EXPERIMENTAL

Cohort A - Low Dose or Sham

Drug: PER-001 Intravitreal Implant - Low Dose; Drug: PER-001 Intravitreal Implant - Sham

Phase 2 Cohort B

EXPERIMENTAL

Cohort B - High Dose or Sham

Drug: PER-001 Intravitreal Implant - High Dose; Drug: PER-001 Intravitreal Implant - Sham

Interventions

PER-001 Intravitreal Implant - Low Dose DRUG

PER-001 Low Dose Intravitreal Implant

Phase 2 Cohort A

PER-001 Intravitreal Implant - High Dose DRUG

PER-001 High Dose Intravitreal Implant

Phase 2 Cohort B

PER-001 Intravitreal Implant - Sham DRUG

PER-001 Intravitreal Sham

Phase 2 Cohort A; Phase 2 Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perfuse Therapeutics, Inc.: lead

Study Sites (1)

Perfuse Therapeutics, Inc

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo sham
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: August 5, 2023
• Primary Completion: April 3, 2025
• Study Completion: April 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-03

Locations

US (1)