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AMDX-2011P as a Retinal Tracer in Primary Open Angle Glaucoma
NCT06223048Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2023
- Primary completion
- Nov 2024
- Countries
- 1
- Sponsor
- Amydis
- Modality
- Device-based Delivery, Light/Condition-Responsive Prodrugs
- Drugs
- AMDX-2011P
- Conditions
- primary open-angle glaucoma (POAG)
01
Overview
Phase 2, randomised, open-label trial of AMDX-2011P in primary open-angle glaucoma (POAG) (2 arms), sponsored by Amydis. Primary endpoint: AMDX-2011P Adverse Events Profile at 8 days. Started Dec 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
AMDX-2011P 50 mg
Single IV bolus of 50 mg AMDX-2011P.
AMDX-2011P 100 mg
Single IV bolus of 100 mg AMDX-2011P.
03
Who it enrols
Patients with Primary Open Angle Glaucoma in both eyes who can fixate and have clear ocular media.
04
Endpoints
Primary
AMDX-2011P Adverse Events Profile
Secondary
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P
Biological Activity
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