What is AMDX-2011P studying for Primary Open Angle Glaucoma?

AMDX-2011P is being studied to see if it can identify amyloid deposits in the retina of people with Primary Open Angle Glaucoma. This research helps understand the condition better by using a diagnostic tracer. The study is sponsored by Amydis Inc. and evaluates how the drug behaves and its safety.

Who may be eligible for this Primary Open Angle Glaucoma clinical trial?

Adults aged 22 years or older with a diagnosis of primary open angle glaucoma in both eyes may be eligible. Both males and females can join, but you must be able to fixate your eyes and have glaucomatous optic nerve damage. Please review eligibility criteria for more details.

Is there any cost to participate in this Primary Open Angle Glaucoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel arrangements needed.

Actively Recruiting

Phase 2

Age: 22Years +

All Genders

ID06223048

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

Participants Needed

Research Sites

13 weeks

Total Duration

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 drugs 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

Age: 22Years +

All Genders

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)

Research Team

Joyce Simpauco

David Bingaman

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