A Phase 2 interventional study of AMDX-2011P in Primary Open Angle Glaucoma, sponsored by Amydis Inc.. Recruiting at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Amydis Inc. · Phase 2, Interventional, and Diagnostic
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 50 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Amydis Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review
AMDX-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
Plan to share: No
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Amydis Inc.