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

Retina Macula Specialists of Miami, LLC

Status and phase: Unknown; Phase 4

Conditions: Diabetic Macular Edema; Retinal Ischemia; Diabetic Retinopathy

Treatments: Drug: Ozurdex Drug Implant Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04038125

LCH-0-012-019

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ozurdex Implant

Other group

Description:

Intravitreal injection of Ozurdex implant

Treatment:

Drug: Ozurdex Drug Implant Product