NCT05172401

Oxulumis®, Suprachoroidal Drug Administration of Triesence® in Diabetic Macular Edema

A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment With the Oxulumis®, Suprachoroidal Drug Administration Device Delivering 2.4mg Triesence® With Diabetic Macular Edema

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oxular Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate the safety and tolerability of using the Oxulumis® microcatheterization device to administer Triesence® to the suprachoroidal space in participants with DME.

Detailed description

This 24-week, single-arm, single-dose clinical investigation will evaluate the safety and tolerability and explore the efficacy of the Oxulumis® microcatheterization device to administer Triesence® (triamcinolone acetonide suspension) 2.4 mg to the posterior suprachoroidal space in subjects with DME not responding to standard therapy. After a screening period, approximately 20 eligible subjects will receive a single dose of 2.4 mg Triesence® to the posterior suprachoroidal space. The follow-up period after treatment administration will be up to 24 weeks.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DEVICE	Oxulumis® suprachoroidal microcatheterization administration of Triesence®	Suprachoroidally administered Triamcinolone acetonide (Triesence) 2.4mg/60µl

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2021-12-29
• Last updated: 2023-01-13