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

NCT05697809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Oxular Limited

    lead INDUSTRY

Principal Investigators

  • Friedrich Asmus, MD · Oxular Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2024-12-05
Completion
2024-12-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697809 on ClinicalTrials.gov