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NCT07843849From ClinicalTrials.govRecruiting

Corticosteroid for Diabetic Macular Edema (DME) Study

  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy

At a glance

Phase
Phase 4
Study type
Interventional
Sponsor
Vanderbilt University Medical Center
Enrolment target
20
Started
7 April 2026
Main results due
March 2028
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Vanderbilt Eye Institute

    Nashville, Tennessee, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07843849. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Corticosteroid for Diabetic Macular Edema (DME) Study | Trialion