← Back to searchRecruitingRecruiting
A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma
NCT06223048 · Amydis Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
About this study
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.
Eligibility 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)
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-12-07
Estimated completion: 2025-02
Last updated: 2024-07-30
Interventions
Drug: AMDX-2011P
Primary outcomes
- • AMDX-2011P Adverse Events Profile (8 days)
Sponsor
Amydis Inc. · industry
Contacts & investigators
ContactJoyce Simpauco · contact · joyce@amydis.com · 858-254-7435
ContactDavid Bingaman · contact · david.bingaman@amydis.com
InvestigatorDavid Bingaman · study_director, Amydis Inc.
All locations (3)
Associated Retina ConsultantsRecruiting
Phoenix, Arizona, United States
Global Research ManagementRecruiting
Glendale, California, United States
Eye Research FoundationRecruiting
Newport Beach, California, United States