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

Primary Purpose

Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ozurdex Drug Implant Product
Sponsored by
Retina Macula Specialists of Miami, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • Retina Macula Specialists of Miami, LLCRecruiting
  • Retina Macula Specialists of Miami, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ozurdex Implant

Arm Description

Intravitreal injection of Ozurdex implant

Outcomes

Primary Outcome Measures

Evaluate re perfusion following Ozurdex use.
Determined by OCT-A

Secondary Outcome Measures

Full Information

First Posted
July 26, 2019
Last Updated
March 16, 2020
Sponsor
Retina Macula Specialists of Miami, LLC
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04038125
Brief Title
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
Acronym
ICOD
Official Title
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Macula Specialists of Miami, LLC
Collaborators
Allergan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia
Keywords
Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex Implant
Arm Type
Other
Arm Description
Intravitreal injection of Ozurdex implant
Intervention Type
Drug
Intervention Name(s)
Ozurdex Drug Implant Product
Other Intervention Name(s)
Dexamethasone
Intervention Description
Intravitreal Ozurdex injection
Primary Outcome Measure Information:
Title
Evaluate re perfusion following Ozurdex use.
Description
Determined by OCT-A
Time Frame
6 Months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Shechtman, OD FAAO
Phone
954-816-1038
Email
dshehctman@retinamiami.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Garcia, CCRC
Phone
305-643-8871
Email
pjimenez@retinamiami.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Shechtman, OD FAAO
Organizational Affiliation
Retina Macula Specialists of Miami, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Macula Specialists of Miami, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Gonzalez
Phone
305-655-0411
Email
jgonzalez@retinamiami.com
First Name & Middle Initial & Last Name & Degree
Pamela Garcia
Phone
306-643-8871
Email
pjimenez@retinamiami.com
Facility Name
Retina Macula Specialists of Miami, LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Gonzalez
Phone
305-666-8850
Email
jgonzalez@retinamiami.com
First Name & Middle Initial & Last Name & Degree
Pamela Garcia
Phone
305-643-8871
Email
Pjimenez@retinamiami.com

12. IPD Sharing Statement

Learn more about this trial

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

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