20 Participants NeededMy employer runs this trial

Corticosteroid for Diabetic Macular Edema

SJ
Overseen ByStephen J Kim, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Our current goals include confirming inflammation mediators are biomarkers of DR and DME

The Aim of this project is to measure aqueous PGE2 and inflammatory cytokines before and after treatment of DME with intravitreal corticosteroid injections.

We want to continue the study for one more year as our initial data analysis from the original INSPIRE study shows a possible direct correlation between aqueous biomarkers and DME. We propose treating the DME with corticosteroid to assess the effect upon the intraocular cytokines with inflammation is suppressed.

Are You a Good Fit for This Trial?

This trial is for people with diabetic macular edema (DME), a complication of diabetes that affects the eyes. Participants should have DME and not have conditions or treatments that would interfere with the study, as determined by the researchers.

Inclusion Criteria

I am an adult with type 2 diabetes, moderate NPDR, and DME.

Exclusion Criteria

I have had a vitrectomy surgery in at least one eye.
I have an eye disease that is not caused by diabetes.
I have had an anti-VEGF eye injection in the past 3 months.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Intravitreal dexamethasone implant

Trial Overview

The study tests an injection of dexamethasone (a corticosteroid) directly into the eye to see how it affects inflammation markers in patients with DME. Researchers will measure these markers before and after treatment.

How Is the Trial Designed?

1

Treatment groups

Active Control

Group I: intravitreal corticosteroid implantActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+