NCT05697809

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Oxular Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fifty-two (52) week phase 2 trial with two parts. Part A is an open-label, randomized, single-dose two treatment arm comparison of two dose levels of sustained-release suprachoroidal OXU-001 (DEXAspheres® administered using the Oxulumis® illuminated microcatheterization device) in subjects with Diabetic Macular Edema. \--- Part A was only partially recruited due a non-safety related sponsor decision to stop further recruitment after 3 randomized and treated subjects. \--- Part B is a randomized, masked, active comparator, single-dose, three treatment arm comparison of two dose levels of suprachoroidal OXU-001 and IVT Ozurdex® to evaluate the safety, tolerability, efficacy, and durability in subjects with Diabetic Macular Edema (DME). \--- Part B was not initiated due a non-safety related sponsor decision in Dec 2023. \--- In Part A, after a screening period, approximately 18 adult female or male subjects will be randomized in a 1:1 ratio to receive a single administration of one of two dose levels of OXU-001 (mid-dose or high-dose). In Part B, after a screening period, approximately 110 adult female or male subjects will be randomized in a 2:2:1 ratio to receive a single administration of one of two dose levels of OXU-001 (Dose 1 or Dose 2) or Ozurdex®. From Week 12, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to fifty-two (52) weeks.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	OXU-001	Suprachoroidal sustained release dexamethasone acetate
DEVICE	Semi-automated suprachoroidal illuminated microcatheter	Ophthalmic administration device
DRUG	Ozurdex® Ophthalmic Intravitreal Implant	Ophthalmic dexamethasone intravitreal implant

Timeline

• Start date: 2023-08-07
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2023-01-26
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study
• FDA-regulated device study