Open-angle GlaucomaPhase 1/2NCT05822245
A Study of PER-001 in Participants With Open-Angle Glaucoma
A Phase 1/2 study testing PER-001 Intravitreal Implant - Low Dose and PER-001 Intravitreal Implant - High Dose in people with Open-angle Glaucoma, run by Perfuse Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- PER-001 Intravitreal Implant - Low Dose and PER-001 Intravitreal Implant - High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 20 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Perfuse Therapeutics, Inc.
San Francisco, California, 94158
About this study
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
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.
Read the 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).
- Conditions
- Open-angle Glaucoma
- Being tested
- PER-001 Intravitreal Implant - Low Dose, PER-001 Intravitreal Implant - High Dose, PER-001 Intravitreal Implant - Sham
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PER-001 Intravitreal Implant - Low DoseDrug
PER-001 Low Dose Intravitreal Implant
PER-001 Intravitreal Implant - High DoseDrug
PER-001 High Dose Intravitreal Implant
PER-001 Intravitreal Implant - ShamDrug
PER-001 Intravitreal Sham
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Cohort A | Experimental | Cohort A - Low Dose Receives: Drug: PER-001 Intravitreal Implant - Low Dose |
| Phase 1 Cohort B | Experimental | Cohort B - High Dose Receives: Drug: PER-001 Intravitreal Implant - High Dose |
| Phase 2 Cohort C | Experimental | Cohort C - Low Dose or Sham Receives: Drug: PER-001 Intravitreal Implant - Low Dose; Drug: PER-001 Intravitreal Implant - Sham |
| Phase 2 Cohort D | Experimental | Cohort D - High Dose or Sham Receives: Drug: PER-001 Intravitreal Implant - High Dose; Drug: PER-001 Intravitreal Implant - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Study(Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start25 May 2023
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfuse Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Lai, MD, Study director, Perfuse Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822245
- Sponsor's protocol ID
- PER001-201
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05822245
- Acronym / sponsor ID
- PER001-201
- Conditions
- Open-angle Glaucoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Perfuse Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Cohort A | Experimental | Drug: PER-001 Intravitreal Implant - Low DoseCohort A - Low Dose |
| Phase 1 Cohort B | Experimental | Drug: PER-001 Intravitreal Implant - High DoseCohort B - High Dose |
| Phase 2 Cohort C | Experimental | Drug: PER-001 Intravitreal Implant - Low Dose, Drug: PER-001 Intravitreal Implant - ShamCohort C - Low Dose or Sham |
| Phase 2 Cohort D | Experimental | Drug: PER-001 Intravitreal Implant - High Dose, Drug: PER-001 Intravitreal Implant - ShamCohort D - High Dose or Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PER-001 Intravitreal Implant - Low DosePER-001 Low Dose Intravitreal Implant | Drug | Phase 1 Cohort A, Phase 2 Cohort C |
| PER-001 Intravitreal Implant - High DosePER-001 High Dose Intravitreal Implant | Drug | Phase 1 Cohort B, Phase 2 Cohort D |
| PER-001 Intravitreal Implant - ShamPER-001 Intravitreal Sham | Drug | Phase 2 Cohort C, Phase 2 Cohort D |
Primary outcome
Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA)
Time frame: End of Study(Week 24)
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
Time frame: End of Study(Week 24)
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)
Time frame: End of Study(Week 24)
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
Time frame: End of Study(Week 24)
Dilated ophthalmoscopy examination will include evaluation of the vitreous, macula, retinal vessels, peripheral retina, and optic disc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Lai, MD study director
Perfuse Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PER-001 Intravitreal Implant - Low Dose and PER-001 Intravitreal Implant - High Dose in people with Open-angle Glaucoma, run by Perfuse Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA) (time frame: End of Study(Week 24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.