Suprachoroidal Triamcinolone acetonide 2.4mg for Diabetic Macular Edema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Macular EdemaTriamcinolone Acetonide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.

Eligible Conditions
  • Diabetic Macular Edema

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 24 Weeks

24 Weeks
Frequency of adverse device effects and frequency of serious adverse device effects
Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Suprachoroidal Triamcinolone acetonide 2.4mg
1 of 2
Suprachoroidal Triamcinolone acetonide 4.0 mg
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Suprachoroidal Triamcinolone acetonide 2.4mg · No Placebo Group · Phase 2

Suprachoroidal Triamcinolone acetonide 2.4mgExperimental Group · 2 Interventions: Triamcinolone Acetonide, Semi-automated Suprachoroidal Microcatheter · Intervention Types: Drug, Device
Suprachoroidal Triamcinolone acetonide 4.0 mgExperimental Group · 2 Interventions: Triamcinolone Acetonide, Semi-automated Suprachoroidal Microcatheter · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2017
Completed Phase 4
~3470

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Oxular LimitedLead Sponsor
1 Previous Clinical Trials
Friedrich Asmus, MDStudy DirectorOxular Limited
1 Previous Clinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 1 or type 2 diabetes mellitus.
You have diabetic macular edema involving the center of the fovea in the study eye.