Recruiting

Ozurdex

Sponsor:

Retina Macula Specialists of Miami, LLC

Code:

NCT04038125

Conditions

Diabetic Macular Edema

Diabetic Retinopathy

Retinal Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ozurdex Drug Implant Product

Study Details

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).

Conditions

Diabetic Macular Edema

Diabetic Retinopathy

Retinal Ischemia

Study ID

NCT04038125

Start date

Aug 22, 2019

Status verified date

Mar, 2020

Completion date

Aug, 2021

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Ozurdex Implant

Intravitreal injection of Ozurdex implant

Interventions

Ozurdex Drug Implant Product

Intravitreal Ozurdex injection

Primary outcome measure

  • Evaluate re perfusion following Ozurdex use. [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Locations

Retina Macula Specialists of Miami, LLC

Recruiting

North Miami Beach, Florida, United States, 33162

Contacts

Retina Macula Specialists of Miami, LLC

Recruiting

South Miami, Florida, United States, 33143

Contacts

More Information

Sponsor

Retina Macula Specialists of Miami, LLC

Last update posted

Mar 18, 2020

Last verified

Mar, 2020

Keywords

  • Diabetic Macula Edema
  • Diabetic Retinopathy
  • Retina Ischemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Retina Macula Specialists of Miami, LLC on 2020-03-18.