Actively Recruiting
Phase 2 Randomized Open Label Study of AMDX-2011P as a Retinal Tracer in Primary Open Angle Glaucoma
Led by Amydis Inc. · Updated on 2024-07-30
50
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying AMDX-2011P to see if it can detect amyloid deposits in the retina of people with Primary Open Angle Glaucoma (POAG). This Phase 2, open-label study will assess the safety, tolerability, plasma pharmacokinetics, and biological activity of AMDX-2011P given intravenously. Retinal images will be evaluated by masked assessors to ensure unbiased analysis. Participants will receive a single intravenous bolus injection of AMDX-2011P at either 50 mg or 100 mg dose. Before the injection, eye exams and retinal imaging are performed. After administration, safety checks, retinal imaging, blood collection, and pharmacokinetic assessments will be conducted to monitor the drug's behavior in the body. During the study, participants will undergo eye examinations and retinal imaging to record baseline and post-injection changes. Blood samples will be collected for pharmacokinetic analysis within 2 hours after dosing. Safety will be monitored for 8 days following the injection, focusing on any adverse events. Biological activity will also be assessed within one day. The total participation time includes initial assessments and follow-up safety monitoring.
CONDITIONS
Brief Title
A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary open angle glaucoma in both eyes
- Able to fixate
- Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam
You will not qualify if you...
- Participants unable to read or write
- Ocular media is not sufficiently clear to obtain acceptable quality images
- Presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous bolus injection of AMDX-2011P followed by safety assessments, retinal imaging, and blood collection to evaluate pharmacokinetics and biological activity.
1 treatment visit with multiple assessments within the day
Duration - 8 days
Participants are monitored for adverse events and safety for 8 days following the treatment.
Approximately 2 follow-up visits
Trial Site Locations
Total: 3 locations
1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Actively Recruiting
2
Global Research Management
Glendale, California, United States, 91204
Actively Recruiting
3
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
J
Joyce Simpauco
D
David Bingaman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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