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

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retina Macula Specialists of Miami, LLC
• Collaborator: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

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.