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RecruitingAccepts healthy volunteersPhase 4

Corticosteroid for Diabetic Macular Edema (DME) Study

Vanderbilt University Medical Center · NCT07843849

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
20
US sites recruiting
1
Study start
April 7, 2026
Record last updated
September 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Intravitreal dexamethasone implant; Intravitreal dexamethasone implant

Conditions: Diabetic Macular Edema (DME); Diabetic Retinopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Vanderbilt Eye Institute

    Nashville, TN 37232

    Site contact: Lindsay Veach · 6154218216 · lindsay.veach@vumc.org

Study contacts (from the official record)

  • Stephen J Kim, MD · 615-936-2020 · lindsay.veach@vumc.org
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Corticosteroid for Diabetic Macular Edema (DME) Study (NCT07843849) | Bored Studies