Dexamethasone Eye Implant for Diabetic Macular Edema and Its Effect on Eye Inflammation Markers
Tests a dexamethasone eye implant in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Corticosteroid for Diabetic Macular Edema (DME) Study
Key facts
- Where
- Nashville, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Vanderbilt Eye InstituteNashville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT07843849
- Record updated
- 28 September 2026
- Original description
Our current goals include confirming inflammation mediators are biomarkers of DR and DMERead full original descriptionShow less
Corticosteroid for Diabetic Macular Edema (DME) Study
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.
Inclusion: Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.
Exclusion: Patients with a history of previous vitrectomy in either eye; prior antivegf intravitreal injection within 3 months; co-existent non diabetic macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure > 180/110 mmHg; risk for corneal melting; and inability to comply with follow-up.