Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional study investigates the effect of intravitreal dexamethasone implants on inflammatory cytokines and prostaglandin E2 in the aqueous humor of adults with diabetic macular edema and moderate nonproliferative diabetic retinopathy. Measurements are planned before and after treatment to explore relationships between intraocular inflammation and DME. The study builds on INSPIRE data suggesting a link between biomarkers and DME and aims to determine whether reducing inflammation alters biomarker levels and clinical outcomes. Recruitment centers at Vanderbilt Eye Institute in Nashville will enroll eligible participants under ongoing follow-up. The sponsor is Vanderbilt University Medical Center, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanderbilt Eye Institute
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Stephen J Kim, MD
• Email: lindsay.veach@vumc.org
• Phone: 615-936-2020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral N-Acetylcysteine for Diabetic Macular Edema

  This study tests whether taking N-acetylcysteine by mouth can help people with center-involving diabetic macular edema who don’t yet need anti-VEGF therapy.

  Recruiting Phase 2 Tanta University · Damietta · NCT07917338

• 4D-150 gene therapy injected into the eye for adults with diabetic macular edema

  This study tests whether a one-time intravitreal injection of 4D-150 can help adults with diabetic macular edema compare to aflibercept.

  Recruiting at 23 sites Phase 3 4D Molecular Therapeutics · Scottsdale, Arizona and 93 other locations · NCT07867080

• Oral BGE-102 for center-involved diabetic macular edema (Phase 2)

  This trial tests whether taking BGE-102 by mouth, alone or with an anti-VEGF drug, can help preserve or improve vision in adults with center-involved diabetic macular edema.

  Recruiting at 16 sites Phase 2 BioAge Labs, Inc. · Bakersfield, California and 15 other locations · NCT07812090

• Automated detection of diabetic retinopathy lesions in fundus photos

  This study tests a smart imaging system within the DDART device to see if it can reliably spot diabetic retinopathy lesions in color fundus photographs.

  Recruiting Democritus University of Thrace · Alexandroupoli · NCT07758582

• Retinal microvascular changes in diabetic retinopathy measured with OCTA

  This observational study tests how retinal blood vessel patterns seen on OCTA relate to vision and blood sugar control in adults with diabetic retinopathy.

  Recruiting Sohag University · Sohag · NCT07747428

• Tabirafusp Tedromer vs Aflibercept for Diabetic Macular Edema (DME)

  This study tests whether Tabirafusp Tedromer can work as well as or better than Aflibercept to help people with Diabetic Macular Edema.

  Recruiting at 52 sites Phase 3 Kodiak Sciences Inc · Scottsdale, Arizona and 51 other locations · NCT07734844

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.