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NCT06223048 Clinical Trial

A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06223048
Other study ID # AMDX-2011P-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 7, 2023
Est. completion date July 2024

Study information
Verified date March 2024
Source Amydis Inc.
Contact Joyce Simpauco
Phone 858-254-7435
Email joyce@amydis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

Locations
Country Name City State
United States Global Research Management Glendale California
United States Eye Research Foundation Newport Beach California
United States Associated Retina Consultants Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Amydis Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary AMDX-2011P Adverse Events Profile Incidence, nature and severity of AEs/SAEs 8 days
Secondary Concentration of AMDX-2011P Plasma PK Concentration (CMax) 2 hours
Secondary Pharmacokinetic Analysis of AMDX-2011P Area under the plasma versus time curve (AUC) 2 hours
Secondary Biological Activity Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device. 1 day
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