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PER-001 Intravitreal Implant for Open-Angle Glaucoma
Phase 1 & 2
Recruiting
Research Sponsored by Perfuse Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study(week 24)
Awards & highlights
Study Summary
This trial has two parts: an open-label phase (1) and a randomized, masked phase (2a). Participants receive either a real or sham treatment.
Who is the study for?
This trial is for adults over 18 with advanced or severe primary open-angle glaucoma (OAG), including normal tension, pseudoexfoliation, and pigment dispersion. Participants must have an intraocular pressure (IOP) of 6-25 mmHg and a visual acuity score indicating they can see well enough to participate. Pregnant women or those planning pregnancy are excluded, as are individuals with certain eye conditions or recent eye surgeries.Check my eligibility
What is being tested?
The study tests PER-001 Intravitreal Implant at different doses compared to a sham procedure in two phases: Phase 1 where all receive the implant at increasing doses, and Phase 2a which is randomized and single-masked meaning participants don't know if they're getting the real treatment or a sham.See study design
What are the potential side effects?
While specific side effects aren't listed here, intravitreal implants like PER-001 may cause eye redness, discomfort or pain at the injection site, increased eye pressure, bleeding inside the eye (hemorrhage), cataract formation, retinal detachment among other potential ocular complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study(week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study(week 24)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ocular Measurement and Implant Assessment for Safety - Change from Baseline at Week 24 using Dilated Ophthalmoscopy
Ocular Measurement for Safety - Change from Baseline at Week 24 using Best-corrected Visual Acuity (BCVA)
Ocular Measurement for Safety - Change from Baseline at Week 24 using Biomicroscopy
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort DExperimental Treatment2 Interventions
Cohort D - High Dose or Sham
Group II: Phase 2 Cohort CExperimental Treatment2 Interventions
Cohort C - Low Dose or Sham
Group III: Phase 1 Cohort BExperimental Treatment1 Intervention
Cohort B - High Dose
Group IV: Phase 1 Cohort AExperimental Treatment1 Intervention
Cohort A - Low Dose
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Who is running the clinical trial?
Perfuse Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Phillip Lai, MDStudy DirectorPerfuse Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed my eye pressure treatment in the last 6 weeks and don't plan to change it during the study.I do not have any active severe eye infections.I have had eye surgery for a detached retina or a severe macular hole.I have not had retinal laser treatment in the last 3 months.I am not pregnant, nursing, or planning to become pregnant during the study.My primary open-angle glaucoma is getting worse in the study eye.My eye pressure is between 6 and 25 mmHg.I do not have a natural lens in my eye or part of it is missing.I have had repeated eye infections or inflammation.I have not had eye surgery, including for cataracts or glaucoma, in the last 3 months.I have been diagnosed with central serous retinopathy.My vision, with correction, is good enough in at least one eye.My diabetic eye condition is not severe and has been stable.I have or had inflammation in my eye related to an autoimmune condition.I have optic nerve damage not caused by glaucoma.I am 18 years or older and can give informed consent.I have been diagnosed with advanced or severe open-angle glaucoma.My vision score is good enough in at least one eye for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Cohort D
- Group 2: Phase 1 Cohort B
- Group 3: Phase 2 Cohort C
- Group 4: Phase 1 Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for new participants in this investigation?
"As per the clinicaltrials.gov website, this investigation is currently open for enrolment. The trial was uploaded on April 17th 2023 and last updated a week later."
Answered by AI
What is the size of the patient cohort involved in this clinical investigation?
"Affirmative. According to the information archived on clinicaltrials.gov, this research project is currently recruiting participants with a recruitment goal of 36 patients from one medical centre. This trial was first posted online on April 17th 2023 and has since been updated on April 25th 2023."
Answered by AI
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