NCT05822245CompletedPhase 1/2
A Study of PER-001 in Participants With Open-Angle Glaucoma
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 27 Mar 2023
- Start date
- 25 May 2023
- Primary completion date
- 20 Apr 2025
- Lead sponsor
- Perfuse Therapeutics, Inc.
- Diseases
- Glaucoma
- NCT number
- NCT05822245
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 33
- From 25 May 2023 to the primary completion date, 20 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Other illness
- 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)
- History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)
- Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated uveitis
- History of recurrent infectious or inflammatory ocular disease
Other
- Blood pressure \>140/90 mmHg or \<90/60 mmHg at Screening
- 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
- Aphakia or absence of posterior capsule
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild blepharitis is permitted if stable)
- Central serous retinopathy
- Non-glaucomatous optic neuropathy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perfuse Therapeutics, Inc. Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.