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Corticosteroid for Diabetic Macular Edema (DME) Study

RecruitingPhase 4Healthy volunteers welcome

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.

Exclusion Criteria:

* 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.

About the 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.

What is being tested

Sponsor: Vanderbilt University Medical Center · Participants: 20 · Started: Apr 7, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07843849

Locations in the U.S.

TennesseeVanderbilt Eye Institute, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.