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NCT05697809Not yet recruiting

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

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)
Oxular LimitedPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
OXU-001
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Oxular Limited
Timeline & enrollment
Phase
Phase 2
Start date
Mar 15, 2023
End date
Mar 01, 2025
Enrollment
128 participants
Primary outcome

Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest,Frequency and severity of treatment-emergent device adverse effects

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.

ICD-10 classifications
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05697809
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05697809 through Pure Global AI's free database. This Phase 2 trial is sponsored by Oxular Limited and is currently Not yet recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 128 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.