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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06223048

Enrollment

Registered

2024-01-25

Start date

2023-12-07

Completion date

2025-02-28

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma

Keywords

POAG

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).

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.

Interventions

DRUGAMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Phase 2, randomized, parallel arm, open-label, masked endpoint study

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

Primary ContactJoyce Simpauco

joyce@amydis.com858-254-7435

Backup ContactDavid Bingaman

david.bingaman@amydis.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026