Corticosteroid for Diabetic Macular Edema (DME) Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Intravitreal dexamethasone implant
Drugintravitreal dexamethasone 0.7mg implant
Intravitreal dexamethasone implant
Drugfluocinolone acetonide 0.19mg implant
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: intravitreal corticosteroid implantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To measure aqueous IL-6, IL-8, FLT-3L, FGF-2, and IL-10 before and after treatment with intravitreal corticosteroid.
We believe the above cytokines drive the formation of DME and that the therapeutic effects upon DME by corticosteroids are due to reduction of cytokine levels.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov