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

March 16, 2020 updated by: Diana Shechtman, OD FAAO, Retina Macula Specialists of Miami, LLC

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Ozurdex Implant
Intravitreal injection of Ozurdex implant
Drug: Ozurdex Drug Implant Product
Intravitreal Ozurdex injection
Other Names:
  • Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate re perfusion following Ozurdex use.
Time Frame: 6 Months
Determined by OCT-A
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Macula Specialists of Miami, LLC

Collaborators

Allergan

Investigators

  • Principal Investigator: Diana Shechtman, OD FAAO, Retina Macula Specialists of Miami, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2019

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (ACTUAL)

July 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCH-0-012-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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