Trial | NCT04038125  Report issue

Title

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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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).
Study Started
Aug 22
2019
Primary Completion
Aug 31
2020
Anticipated
Study Completion
Aug 31
2021
Anticipated
Last Update
Mar 18
2020

Drug Ozurdex Drug Implant Product

Intravitreal Ozurdex injection

  • Other names: Dexamethasone

Ozurdex Implant Other

Intravitreal injection of Ozurdex implant

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Have had any prior ocular treatment.
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.
No Results Posted