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NCT04038125 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

— ICOD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04038125
Other study ID # LCH-0-012-019
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 22, 2019
Est. completion date August 2021

Study information
Verified date March 2020
Source Retina Macula Specialists of Miami, LLC
Contact Diana Shechtman, OD FAAO
Phone 954-816-1038
Email dshehctman@retinamiami.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ozurdex Drug Implant Product
Intravitreal Ozurdex injection

Locations
Country Name City State
United States Retina Macula Specialists of Miami, LLC North Miami Beach Florida
United States Retina Macula Specialists of Miami, LLC South Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
Retina Macula Specialists of Miami, LLC Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate re perfusion following Ozurdex use. Determined by OCT-A 6 Months
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