Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
ICOD
1 other identifier
interventional
20
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
August 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 18, 2020
March 1, 2020
12 months
July 26, 2019
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate re perfusion following Ozurdex use.
Determined by OCT-A
6 Months
Study Arms (1)
Ozurdex Implant
OTHERIntravitreal injection of Ozurdex implant
Interventions
Intravitreal Ozurdex injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Retina Macula Specialists of Miami, LLClead
- Allergancollaborator
Study Sites (2)
Retina Macula Specialists of Miami, LLC
North Miami Beach, Florida, 33162, United States
Retina Macula Specialists of Miami, LLC
South Miami, Florida, 33143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Shechtman, OD FAAO
Retina Macula Specialists of Miami, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - OD, FAAO
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
August 22, 2019
Primary Completion
August 1, 2020
Study Completion
August 1, 2021
Last Updated
March 18, 2020
Record last verified: 2020-03