Status:
UNKNOWN
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
Lead Sponsor:
Retina Macula Specialists of Miami, LLC
Collaborating Sponsors:
Allergan
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 densi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04038125
Start Date
August 22 2019
End Date
August 1 2021
Last Update
March 18 2020
Active Locations (2)
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1
Retina Macula Specialists of Miami, LLC
North Miami Beach, Florida, United States, 33162
2
Retina Macula Specialists of Miami, LLC
South Miami, Florida, United States, 33143