Recruiting
Phase 2

AMDX-2011P

Sponsor:

Amydis Inc.

Code:

NCT06223048

Conditions

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

AMDX-2011P

Study Details

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).

Conditions

Primary Open Angle Glaucoma

Study ID

NCT06223048

Start date

Dec 7, 2023

Status verified date

Jul, 2024

Completion date

Feb, 2025

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: AMDX-2011P 50 mg

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

experimental: AMDX-2011P 100 mg

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

Interventions

AMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Primary outcome measure

  • AMDX-2011P Adverse Events Profile [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

Joyce Simpauco

858-254-7435joyce@amydis.com

David Bingaman

david.bingaman@amydis.com

Locations

Associated Retina Consultants

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

Mallory Mintert

mallory.mintert@doctrials.com

Global Research Management

Recruiting

Glendale, California, United States, 91204

Contacts

Logi El-Harazi

logi@grmclinical.com

Eye Research Foundation

Recruiting

Newport Beach, California, United States, 92663

Contacts

Linda Wirta

linda.wirta@drwirta.com

More Information

Sponsor

Amydis Inc.

Last update posted

Jul 30, 2024

Last verified

Jul, 2024

Keywords

  • POAG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amydis Inc. on 2024-07-30.