Clinical Trials Logo
  1. Home
  2. Diabetic Retinopathy
  3. NCT04038125
  4. Details
NCT04038125 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

— ICOD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04038125
Other study ID # LCH-0-012-019
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 22, 2019
Est. completion date August 2021

Study information
Verified date March 2020
Source Retina Macula Specialists of Miami, LLC
Contact Diana Shechtman, OD FAAO
Phone 954-816-1038
Email dshehctman@retinamiami.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Ozurdex Drug Implant Product
Intravitreal Ozurdex injection

Locations
Country Name City State
United States Retina Macula Specialists of Miami, LLC North Miami Beach Florida
United States Retina Macula Specialists of Miami, LLC South Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
Retina Macula Specialists of Miami, LLC Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate re perfusion following Ozurdex use. Determined by OCT-A 6 Months
See also
  Status Clinical Trial Phase
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A