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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional
A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared with Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects with Diabetic Macular Edema (OXEYE).
At a glance
Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Oxular IE Limited
Enrolment target
44
Start
18 Aug 2023
What is this study about?
Both Part A and Part B: Frequency and severity of ocular and systemic adverse events (serious, adverse events of special interest, and treatment-emergent adverse events), Both Part A and Part B: Frequency and severity of device adverse effects (serious adverse device effects and treatment-emergent device adverse effects)
Who may be eligible?
Age 18 Years to any · Sex: All
Locations (2)
- —Hungary
- —Spain
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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