Diabetic RetinopathyPhase 2NCT06003751
A Study of PER-001 in Participants With Diabetic Retinopathy
A Phase 2 study testing PER-001 Intravitreal Implant - Low Dose and PER-001 Intravitreal Implant - High Dose in people with Diabetic Retinopathy, run by Perfuse Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2023to 10 Dec 2025
- Phase
- Phase 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
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 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy
This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
Read the detailed 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).
- Conditions
- Diabetic Retinopathy
- Being tested
- PER-001 Intravitreal Implant - Low Dose, PER-001 Intravitreal Implant - High Dose, PER-001 Intravitreal Implant - Sham
- Medical subject headings
- Diabetic Retinopathy
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 2 Cohort A | Experimental | Cohort A - Low Dose or Sham Receives: Drug: PER-001 Intravitreal Implant - Low Dose; Drug: PER-001 Intravitreal Implant - Sham |
| Phase 2 Cohort B | Experimental | Cohort B - 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.
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
Measured: End of Study(Week 24)
Intraocular Pressure (IOP)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
Measured: 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
Measured: 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
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 posted22 Aug 2023
- Study start5 Aug 2023
- Primary completion3 Apr 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfuse Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003751
- Sponsor's protocol ID
- PER001-202
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06003751
- Acronym / sponsor ID
- PER001-202
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Perfuse Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 22 Aug 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 is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2 Cohort A | Experimental | Drug: PER-001 Intravitreal Implant - Low Dose, Drug: PER-001 Intravitreal Implant - ShamCohort A - Low Dose or Sham |
| Phase 2 Cohort B | Experimental | Drug: PER-001 Intravitreal Implant - High Dose, Drug: PER-001 Intravitreal Implant - ShamCohort B - High Dose or Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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).
- 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.
Key exclusion criteria (21 listed)
- 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).
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 2 Cohort A |
| PER-001 Intravitreal Implant - High DosePER-001 High Dose Intravitreal Implant | Drug | Phase 2 Cohort B |
| PER-001 Intravitreal Implant - ShamPER-001 Intravitreal Sham | Drug | Phase 2 Cohort A, Phase 2 Cohort B |
Primary outcome
Best-corrected Visual Acuity (BCVA)
Time frame: End of Study(Week 24)
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
Intraocular Pressure (IOP)
Time frame: End of Study(Week 24)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
Ocular Adverse events
Time frame: End of Study(Week 24)
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
Systemic Adverse events
Time frame: End of Study(Week 24)
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
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PER-001 Intravitreal Implant - Low Dose and PER-001 Intravitreal Implant - High Dose in people with Diabetic Retinopathy, 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 4 inclusion and 21 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 phase mean?
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?
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.