A Study of PER-001 in Participants With Open-Angle Glaucoma

NCT05822245 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PER001-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, single ascending dose (SAD), while Phase 2a is a randomized, single-masked (participant) with a sham control.

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (4)

• Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA)

  ETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting will be used to calculate the LogMAR score

  End of Study(Week 24)

• Ocular Measurement for Safety - Change from Baseline at Week 24 using Biomicroscopy

  Slit lamp examinations will include evaluation of the lids, conjunctiva, cornea, anterior chamber, iris/pupil, and lens.

  End of Study(Week 24)

• Ocular Measurement for Safety - Change from Baseline at Week 24 using Intraocular Pressure (IOP)

  IOP is measured by a calibrated Goldmann applanation tonometry.

  End of Study(Week 24)

• Ocular Measurement and Implant Assessment for Safety - Change from Baseline at Week 24 using Dilated Ophthalmoscopy

  Dilated ophthalmoscopy examination will include evaluation of the vitreous, macula, retinal vessels, peripheral retina, and optic disc.

  End of Study(Week 24)

Study Arms (4)

Phase 1 Cohort A

EXPERIMENTAL

Cohort A - Low Dose

Drug: PER-001 Intravitreal Implant - Low Dose

Phase 1 Cohort B

EXPERIMENTAL

Cohort B - High Dose

Drug: PER-001 Intravitreal Implant - High Dose

Phase 2 Cohort C

EXPERIMENTAL

Cohort C - Low Dose or Sham

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

Phase 2 Cohort D

EXPERIMENTAL

Cohort D - 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 1 Cohort A; Phase 2 Cohort C

PER-001 Intravitreal Implant - High Dose DRUG

PER-001 High Dose Intravitreal Implant

Phase 1 Cohort B; Phase 2 Cohort D

PER-001 Intravitreal Implant - Sham DRUG

PER-001 Intravitreal Sham

Phase 2 Cohort C; Phase 2 Cohort D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Phase 1 and Phase 2a:
• 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).
• IOP 6 to 25 mmHg (inclusive) at Screening in potentially eligible eye(s)
• Phase 1:
• Best corrected visual acuity (BCVA) LogMAR score 1.0 or better at Screening in at least one eye and prior to randomization at Day 1 in the study eye
• Diagnosis of advanced or severe primary OAG including normal tension, pseudoexfoliation and pigment dispersion
• Phase 2:
• BCVA LogMAR score 0.5 or better at Screening in at least one eye and prior to randomization at Day 1 in the study eye
• Primary OAG that is progressing in the study eye

You may not qualify if:

• Blood pressure \>140/90 mmHg or \<90/60 mmHg at Screening
• 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
• Any significant media opacity which precludes clinical evaluation and imaging of the retina
• History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)
• Retinal laser within 3 months prior to Day 1
• Intraocular surgery, including cataract surgery and Minimally Invasive Glaucoma
• Surgery (MIGS), within 3 months prior to Day 1
• Aphakia or absence of posterior capsule
• Change in IOP lowering therapy within 6 weeks prior to Screening and/or anticipated change in IOP lowering therapy or treatment during the study Worse than mild non-proliferative diabetic retinopathy (Note: stable mild background diabetic retinopathy is permitted)
• Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated uveitis
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild blepharitis is permitted if stable)
• History of recurrent infectious or inflammatory ocular disease
• Central serous retinopathy
• Non-glaucomatous optic neuropathy

Sponsors & Collaborators

• Perfuse Therapeutics, Inc.: lead

Study Sites (1)

Perfuse Therapeutics, Inc.

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Phillip Lai, MD

  Perfuse Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo sham
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 20, 2023
• Study Start: May 25, 2023
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2026
• Last Updated: April 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)