A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma
A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
1 other identifier
interventional
50
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2023
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2023
CompletedFirst Submitted
Initial submission to the registry
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 30, 2024
July 1, 2024
11 months
December 14, 2023
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AMDX-2011P Adverse Events Profile
Incidence, nature and severity of AEs/SAEs
8 days
Secondary Outcomes (3)
Concentration of AMDX-2011P
2 hours
Pharmacokinetic Analysis of AMDX-2011P
2 hours
Biological Activity
1 day
Study Arms (2)
AMDX-2011P 50 mg
EXPERIMENTALAMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
AMDX-2011P 100 mg
EXPERIMENTALAMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Interventions
AMDX-2011P single bolus injection intravenous for diagnostic review
Eligibility Criteria
You may qualify if:
- Diagnosis of primary open angle glaucoma in both eyes
- Able to fixate
- Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam
You may not qualify if:
- Participants unable to read or write
- Ocular media is not sufficiently clear to obtain acceptable quality images
- Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amydis Inc.lead
Study Sites (3)
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Global Research Management
Glendale, California, 91204, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Bingaman
Amydis Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2023
First Posted
January 25, 2024
Study Start
December 7, 2023
Primary Completion
November 1, 2024
Study Completion
February 1, 2025
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share