Diabetic Macular Edema (DME)Phase 4NCT07843849
Corticosteroid for Diabetic Macular Edema (DME) Study
A Phase 4 study testing Intravitreal dexamethasone implant in people with Diabetic Macular Edema (DME) and Diabetic Retinopathy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema (DME), Diabetic Retinopathy
- What is being tested?
- Intravitreal dexamethasone implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to Mar 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Lindsay Veach, 6154218216, lindsay.veach@vumc.org
About this study
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.
- Conditions
- Diabetic Macular Edema (DME), Diabetic Retinopathy
- Being tested
- Intravitreal dexamethasone implant
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal dexamethasone implantDrug
intravitreal dexamethasone 0.7mg implant
Intravitreal dexamethasone implantDrug
fluocinolone acetonide 0.19mg implant
| Study group | Role | What they receive |
|---|---|---|
| intravitreal corticosteroid implant | Active comparator | Not described Receives: Drug: Intravitreal dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start7 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Kim, MD, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843849
- Sponsor's protocol ID
- 250805
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided