A Study of PER-001 in Participants With Open-Angle Glaucoma (NCT05822245) | Clinical Trial Compass
CompletedPhase 1/2
A Study of PER-001 in Participants With Open-Angle Glaucoma
United States33 participantsStarted 2023-05-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA)
Timeframe: End of Study(Week 24)
2
Ocular Measurement for Safety - Change from Baseline at Week 24 using Biomicroscopy
Timeframe: End of Study(Week 24)
3
Ocular Measurement for Safety - Change from Baseline at Week 24 using Intraocular Pressure (IOP)
Timeframe: End of Study(Week 24)
4
Ocular Measurement and Implant Assessment for Safety - Change from Baseline at Week 24 using Dilated Ophthalmoscopy