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Completed
NCT05822245
A Study of PER-001 in Participants With Open-Angle Glaucoma
Conditions: Open-angle Glaucoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 33
Sponsor: Perfuse Therapeutics, Inc.
Location: Perfuse Therapeutics, Inc. San Francisco California
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.
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 \
Source: ClinicalTrials.gov (NCT05822245). StuddyBuddy aggregates publicly available trial information.