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

Amydis

Status and phase: Enrolling; Phase 2

Conditions: Primary Open Angle Glaucoma

Treatments: Drug: AMDX-2011P

Study type: Interventional

Funder types: Industry

Identifiers

NCT06223048

AMDX-2011P-202

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

AMDX-2011P 50 mg

Experimental group

Description:

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

Treatment:

Drug: AMDX-2011P

AMDX-2011P 100 mg

Experimental group

Description:

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

Treatment:

Drug: AMDX-2011P