At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating OXU-001, Semi-automated suprachoroidal illuminated microcatheter, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 3 participants across 9 sites in 2 countries.
Detailed Summary
The purpose of this clinical trial is 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.
Study Details
Timeline
Interventions
Suprachoroidal sustained release dexamethasone acetate
Ophthalmic administration device
Ophthalmic dexamethasone intravitreal implant