Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06223048

A Study of AMDX-2011P 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Associated Retina Consultants, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

AMDX-2011P

Drug

AMDX-2011P single bolus injection intravenous for diagnostic review

Primary outcomes

  1. AMDX-2011P Adverse Events Profile

    Time frame: 8 days

    Incidence, nature and severity of AEs/SAEs

Secondary outcomes

  1. Concentration of AMDX-2011P

    Time frame: 2 hours

    Plasma PK Concentration (CMax)

  2. Pharmacokinetic Analysis of AMDX-2011P

    Time frame: 2 hours

    Area under the plasma versus time curve (AUC)

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Bingaman

CONTACT

[email protected]

Joyce Simpauco

CONTACT

[email protected]

858-254-7435

Sponsors and collaborators

Lead sponsor

Amydis Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 25, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.