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

Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04038125

Acronym

ICOD

Enrollment

Registered

2019-07-30

Start date

2019-08-22

Completion date

2021-08-31

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia

Keywords

Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia

Brief 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).

Interventions

DRUGOzurdex Drug Implant Product

Intravitreal Ozurdex injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years and Older. 2. Diagnosis of diabetes mellitus (type 1 or type 2). 3. At least one eye meets the study eye criteria listed. 4. Visual Acuity 20/30 - 20/200 Snellen equivalent 5. Have received no previous treatment for diabetic macular edema,(treatment naïve) 6. Mild to Severe Non-proliferative Diabetic Retinopathy 7. Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm. 8. Able and willing to provide informed consent.

Exclusion criteria

1. Have had any prior ocular treatment. 2. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy. 4\. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D \>/= 0.5 with correlated NFLA thinning or IOP\>25mmHg). 6. Have a contraindication to Ozurdex.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate re perfusion following Ozurdex use.	6 Months	Determined by OCT-A

Countries

United States

Contacts

Primary ContactDiana Shechtman, OD FAAO

dshehctman@retinamiami.com954-816-1038

Backup ContactPamela Garcia, CCRC

pjimenez@retinamiami.com305-643-8871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026