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

Phase 2

Recruiting

• Conditions: Primary Open Angle Glaucoma
• Interventions: Drug: AMDX-2011P

• Registration Number: NCT06223048
• Lead Sponsor: Amydis Inc.

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.

Study Timeline

• Study Start: 2023-12-07
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-11
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMDX-2011P 50 mg	AMDX-2011P	AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review
AMDX-2011P 100 mg	AMDX-2011P	AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Primary Outcome Measures

Name	Time	Method
AMDX-2011P Adverse Events Profile	8 days	Incidence, nature and severity of AEs/SAEs

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Global Research Management; 🇺🇸 Glendale, California, United States