NCT06223048

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Amydis Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	AMDX-2011P	AMDX-2011P single bolus injection intravenous for diagnostic review

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-11-01
• Completion: 2025-02-01
• First posted: 2024-01-25
• Last updated: 2024-07-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study