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

Primary Purpose

Open-angle Glaucoma

Status
Recruiting
Phase
Phase 1
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 Open-angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Perfuse Therapeutics, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1 Cohort A

Phase 1 Cohort B

Phase 2 Cohort C

Phase 2 Cohort D

Arm Description

Cohort A - Low Dose

Cohort B - High Dose

Cohort C - Low Dose or Sham

Cohort D - High Dose or Sham

Outcomes

Primary Outcome Measures

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
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.
Ocular Measurement for Safety - Change from Baseline at Week 24 using Intraocular Pressure (IOP)
IOP is measured by a calibrated Goldmann applanation tonometry.
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.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
August 7, 2023
Sponsor
Perfuse Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05822245
Brief Title
A Study of PER-001 in Participants With Open-Angle Glaucoma
Official Title
A Phase 1/2a Study to Evaluate Safety, Tolerability, and Pharmacodynamic Effect After Single Administration of PER-001 Intravitreal Implant in Participants With Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
January 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 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.
Detailed Description
This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, SAD study to investigate the ocular and systemic safety and tolerability of two dose levels of PER-001, in participants with advanced OAG. Phase 1 will enroll up to approximately 12 participants. Phase 2a 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 progressing glaucoma. Participants who meet entry criteria will be randomized to receive either dose of PER-001 or sham control. In Phase 2a, 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
Open-angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation.
Masking
Participant
Masking Description
Placebo sham
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Cohort A
Arm Type
Experimental
Arm Description
Cohort A - Low Dose
Arm Title
Phase 1 Cohort B
Arm Type
Experimental
Arm Description
Cohort B - High Dose
Arm Title
Phase 2 Cohort C
Arm Type
Experimental
Arm Description
Cohort C - Low Dose or Sham
Arm Title
Phase 2 Cohort D
Arm Type
Experimental
Arm Description
Cohort D - 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
Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA)
Description
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
Time Frame
End of Study(Week 24)
Title
Ocular Measurement for Safety - Change from Baseline at Week 24 using Biomicroscopy
Description
Slit lamp examinations will include evaluation of the lids, conjunctiva, cornea, anterior chamber, iris/pupil, and lens.
Time Frame
End of Study(Week 24)
Title
Ocular Measurement for Safety - Change from Baseline at Week 24 using Intraocular Pressure (IOP)
Description
IOP is measured by a calibrated Goldmann applanation tonometry.
Time Frame
End of Study(Week 24)
Title
Ocular Measurement and Implant Assessment for Safety - Change from Baseline at Week 24 using Dilated Ophthalmoscopy
Description
Dilated ophthalmoscopy examination will include evaluation of the vitreous, macula, retinal vessels, peripheral retina, and optic disc.
Time Frame
End of Study(Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Melie
Phone
415-294-8750
Email
info@perfusetherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Lai, MD
Organizational Affiliation
Perfuse Therapeutics, Inc.
Official's Role
Study Director
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

12. IPD Sharing Statement

Plan to Share IPD
No

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

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