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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-07

Study Completion Date

2025-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AMDX-2011P 50 mg

AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review

Group Type EXPERIMENTAL

AMDX-2011P

Intervention Type DRUG

AMDX-2011P single bolus injection intravenous for diagnostic review

AMDX-2011P 100 mg

AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Group Type EXPERIMENTAL

AMDX-2011P

Intervention Type DRUG

AMDX-2011P single bolus injection intravenous for diagnostic review

Interventions

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AMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No