Evaluating AMDX-2011P for detecting amyloid deposits in glaucoma patients
A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
PHASE2 · Amydis Inc. · NCT06223048
This study is testing a new drug called AMDX-2011P to see if it can safely help detect amyloid deposits in people with Primary Open Angle Glaucoma.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Amydis Inc. (industry) |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT06223048 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and biological activity of AMDX-2011P in individuals diagnosed with Primary Open Angle Glaucoma (POAG). Participants will undergo a series of eye examinations and retinal imaging before receiving a single intravenous dose of the study drug. Following administration, researchers will conduct safety assessments and monitor plasma pharmacokinetics, while centrally masked assessors will evaluate retinal images for amyloid deposits. The study is designed to provide insights into the potential role of AMDX-2011P in the management of POAG.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Primary Open Angle Glaucoma in both eyes and exhibiting glaucomatous optic nerve damage.
Not a fit: Patients with ocular pathologies other than glaucoma or those unable to read or write may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and treatment of Primary Open Angle Glaucoma by identifying amyloid deposits in the retina.
How similar studies have performed: While the approach of using AMDX-2011P is novel, similar studies targeting amyloid deposits in ocular conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Phoenix, Arizona and 2 other locations
- Associated Retina Consultants — Phoenix, Arizona, United States (RECRUITING)
- Global Research Management — Glendale, California, United States (RECRUITING)
- Eye Research Foundation — Newport Beach, California, United States (RECRUITING)
Study contacts
- Study coordinator: Joyce Simpauco
- Email: joyce@amydis.com
- Phone: 858-254-7435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Open Angle Glaucoma, POAG