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Recruiting NCT07843849

Corticosteroid for Diabetic Macular Edema (DME) Study

Conditions: Diabetic Macular Edema (DME), Diabetic Retinopathy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 20
Sponsor: Vanderbilt University Medical Center

Location: Vanderbilt Eye Institute Nashville Tennessee

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07843849). StuddyBuddy aggregates publicly available trial information.