Recruiting

Corticosteroid

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07843849

Conditions

Diabetic Macular Edema (DME)

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intravitreal dexamethasone implant

Intravitreal dexamethasone implant

Study Details

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.

Conditions

Diabetic Macular Edema (DME)

Diabetic Retinopathy

Study ID

NCT07843849

Start date

Apr 7, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: intravitreal corticosteroid implant

Interventions

Intravitreal dexamethasone implant

intravitreal dexamethasone 0.7mg implant

Intravitreal dexamethasone implant

fluocinolone acetonide 0.19mg implant

Primary outcome measure

  • To measure aqueous IL-6, IL-8, FLT-3L, FGF-2, and IL-10 before and after treatment with intravitreal corticosteroid. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Stephen J Kim, MD

615-936-2020lindsay.veach@vumc.org

Locations

Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lindsay Veach

6154218216lindsay.veach@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Sep 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.