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

March 21, 2024 updated by: Amydis Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
    • California
      • Glendale, California, United States, 91204
      • Newport Beach, California, United States, 92663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMDX-2011P 100 mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review
Experimental: AMDX-2011P 50 mg
AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMDX-2011P Adverse Events Profile
Time Frame: 8 days
Incidence, nature and severity of AEs/SAEs
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of AMDX-2011P
Time Frame: 2 hours
Plasma PK Concentration (CMax)
2 hours
Pharmacokinetic Analysis of AMDX-2011P
Time Frame: 2 hours
Area under the plasma versus time curve (AUC)
2 hours
Biological Activity
Time Frame: 1 day
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amydis Inc.

Investigators

  • Study Director: David Bingaman, Amydis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDX-2011P-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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