A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
Amydis Inc.
Summary
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).
Description
This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors. Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of primary open angle glaucoma in both eyes 2. Able to fixate 3. Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam Exclusion Criteria: 1. Participants unable to read or write 2. Ocular media is not sufficiently clear to obtain acceptable quality images 3. Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Interventions
- DrugAMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review
Locations (3)
- Associated Retina ConsultantsPhoenix, Arizona
- Global Research ManagementGlendale, California
- Eye Research FoundationNewport Beach, California