Corticosteroid for Diabetic Macular Edema (DME) Study
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2026
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2026
CompletedFirst Submitted
Initial submission to the registry
September 16, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
September 28, 2026
August 1, 2026
1.9 years
September 16, 2026
September 21, 2026
Conditions
Outcome Measures
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.
12 months
Study Arms (1)
intravitreal corticosteroid implant
ACTIVE COMPARATORInterventions
intravitreal dexamethasone 0.7mg implant
Eligibility Criteria
You may qualify if:
- Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology & Visual Sciences
Study Record Dates
First Submitted
September 16, 2026
First Posted
September 28, 2026
Study Start
April 7, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
September 28, 2026
Record last verified: 2026-08