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

Phase 4

• Conditions: Diabetic Macular Edema; Diabetic Retinopathy; Retinal Ischemia
• Interventions: Drug: Ozurdex Drug Implant Product

• Registration Number: NCT04038125
• Lead Sponsor: Retina Macula Specialists of Miami, LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-30
• Study Start: 2019-08-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

3. 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex Implant	Ozurdex Drug Implant Product	Intravitreal injection of Ozurdex implant

Primary Outcome Measures

Name	Time	Method
Evaluate re perfusion following Ozurdex use.	6 Months	Determined by OCT-A

Trial Locations

Locations (1)

Retina Macula Specialists of Miami, LLC; 🇺🇸 South Miami, Florida, United States