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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of primary open angle glaucoma in both eyes
Able to fixate
Must not have
Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if AMDX-2011P can be used to detect amyloid deposits in the retina of individuals with Primary Open Angle Glaucoma (POAG).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with open angle glaucoma in both eyes.
Select...
I can focus my eyesight on a specific point.
Select...
I have glaucoma damage in both eyes confirmed by an eye exam.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have glaucoma or cataracts but no other eye conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AMDX-2011P Adverse Events Profile
Secondary study objectives
Biological Activity
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: AMDX-2011P 50 mgExperimental Treatment1 Intervention
AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
Group II: AMDX-2011P 100 mgExperimental Treatment1 Intervention
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
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Who is running the clinical trial?
Amydis Inc.Lead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
David BingamanStudy DirectorAmydis Inc.
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