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

Diabetic Macular Edema Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT05172401
• Study type: Interventional
• Source: Oxular Limited
• Status: Withdrawn
• Phase: N/A
• Start date: September 15, 2022
• Completion date: January 31, 2023