A Study of PER-001 in Participants With Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003751
• Other study ID #: PER001-202
• Status: Recruiting
• Phase: Phase 2
• Start date: August 5, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: Perfuse Therapeutics, Inc.
• Contact: Andrew Melie
• Phone: 415-294-8750
• Email: info[@]perfusetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 31, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• PER-001 Intravitreal Implant - Low Dose
PER-001 Low Dose Intravitreal Implant
• PER-001 Intravitreal Implant - High Dose
PER-001 High Dose Intravitreal Implant
• PER-001 Intravitreal Implant - Sham
PER-001 Intravitreal Sham

Locations

Country	Name	City	State
United States	Perfuse Therapeutics, Inc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Perfuse Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Intraocular Pressure (IOP)	IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.	End of Study(Week 24)
Primary	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)
Primary	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)