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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
50
AMDX-2011P single bolus injection intravenous for diagnostic review
Associated Retina Consultants
Phoenix, Arizona, United States
RECRUITINGGlobal Research Management
Glendale, California, United States
RECRUITINGEye Research Foundation
Newport Beach, California, United States
RECRUITINGAMDX-2011P Adverse Events Profile
Incidence, nature and severity of AEs/SAEs
Time frame: 8 days
Concentration of AMDX-2011P
Plasma PK Concentration (CMax)
Time frame: 2 hours
Pharmacokinetic Analysis of AMDX-2011P
Area under the plasma versus time curve (AUC)
Time frame: 2 hours
Biological Activity
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.