drugset / Trial / NCT05697809

Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

NCT05697809 ↗

Phase 2 Completed 3 enrolled Oxular Limited
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-08-07
Primary completion
2024-12-05
Completion
2024-12-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule — Intravitreal
Subject OXU-001 Unknown — Other