Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
NCT ID: NCT04038125
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2019-08-22
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ozurdex Implant
Intravitreal injection of Ozurdex implant
Ozurdex Drug Implant Product
Intravitreal Ozurdex injection
Interventions
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Ozurdex Drug Implant Product
Intravitreal Ozurdex injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Retina Macula Specialists of Miami, LLC
OTHER
Responsible Party
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Diana Shechtman, OD FAAO
Principal Investigator - OD, FAAO
Principal Investigators
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Diana Shechtman, OD FAAO
Role: PRINCIPAL_INVESTIGATOR
Retina Macula Specialists of Miami, LLC
Locations
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Retina Macula Specialists of Miami, LLC
North Miami Beach, Florida, United States
Retina Macula Specialists of Miami, LLC
South Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCH-0-012-019
Identifier Type: -
Identifier Source: org_study_id
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