UnknownPhase 4

Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

United States20 participantsStarted 2019-08-22

Plain-language summary

The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years and Older.
✓. Diagnosis of diabetes mellitus (type 1 or type 2).
✓. At least one eye meets the study eye criteria listed.
✓. Visual Acuity 20/30 - 20/200 Snellen equivalent
✓. Have received no previous treatment for diabetic macular edema,(treatment naïve)
✓. Mild to Severe Non-proliferative Diabetic Retinopathy
✓. Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
✓. Able and willing to provide informed consent.

Exclusion criteria

✕. Have had any prior ocular treatment.
✕. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.

What they're measuring

Evaluate re perfusion following Ozurdex use.

Timeframe: 6 Months

Trial details

NCT IDNCT04038125

SponsorRetina Macula Specialists of Miami, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08

Contact for this trial

Diana Shechtman, OD FAAO

954-816-1038 dshehctman@retinamiami.com

View on ClinicalTrials.gov More Diabetic Macular Edema trials