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RecruitingNCT07843849Updated Sep 28, 2026

Corticosteroid for Diabetic Macular Edema (DME) Study

A Phase 4 interventional study of Intravitreal dexamethasone implant and Intravitreal dexamethasone implant in Diabetic Macular Edema (DME) and Diabetic Retinopathy, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    intravitreal corticosteroid implant

    Drug: Intravitreal dexamethasone implant

Interventions

  • DrugIntravitreal dexamethasone implant

    intravitreal dexamethasone 0.7mg implant

  • DrugIntravitreal dexamethasone implant

    fluocinolone acetonide 0.19mg implant

05

What researchers measure

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 months

06

Study locations

1 of 1 sites recruiting
  • Vanderbilt Eye Institute
    Nashville, Tennessee 37232, United States
    Recruiting
07

References and documents

Study documents

  • Study protocol · Mar 1, 2026
  • Informed consent form · Apr 1, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07843849
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Stephen J. Kim, MD (Professor of Ophthalmology & Visual Sciences, Vanderbilt University Medical Center) — Principal investigator
First posted
Sep 28, 2026
Start date
Apr 7, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Stephen J Kim, MD
Contact
lindsay.veach@vumc.org
615-936-2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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