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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMDX-2011P 50 mg | Experimental | AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review |
|
| AMDX-2011P 100 mg | Experimental | AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMDX-2011P | Drug | AMDX-2011P single bolus injection intravenous for diagnostic review |
|
| Measure | Description | Time Frame |
|---|---|---|
| AMDX-2011P Adverse Events Profile | Incidence, nature and severity of AEs/SAEs | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of AMDX-2011P | Plasma PK Concentration (CMax) | 2 hours |
| Pharmacokinetic Analysis of AMDX-2011P | Area under the plasma versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce Simpauco | Contact | 858-254-7435 | joyce@amydis.com | |
| David Bingaman | Contact | david.bingaman@amydis.com |
| Name | Affiliation | Role |
|---|---|---|
| David Bingaman | Amydis Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Recruiting | Phoenix | Arizona | 85020 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Phase 2, randomized, parallel arm, open-label, masked endpoint study
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| 2 hours |
| Biological Activity | Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device. | 1 day |
| Global Research Management | Recruiting | Glendale | California | 91204 | United States |
|
| Eye Research Foundation | Recruiting | Newport Beach | California | 92663 | United States |
|