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Corticosteroid for Diabetic Macular Edema (DME) Study

RecruitingPhase 4Ages 18 Years - anyAllVanderbilt University Medical Center
NCT07843849 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intravitreal dexamethasone implant
  • Intravitreal dexamethasone implant
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Where

1 site
Vanderbilt Eye Institute
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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