Status:
UNKNOWN
The Effects of Intravitreal Ozurdex Implant in DME
Lead Sponsor:
Nune Eye Hospital, Seoul, Korea
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in...
Eligibility Criteria
Inclusion
- The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
- Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
- Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
- Diabetic patients with cystoids macular edema
- Minimum central thickness on OCT not less than 300 microns
- BCVA 20/30\~20/320
Exclusion
- Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
- Patients with history of ocular hypertension or glaucoma
- Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
- Patients with macular ischemia on FFA
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
- Patients whose posterior lens capsule is not intact.
- patients with known hypersensitivity to any components of this product.
- patients with vitreous hemorrhage
- patients who have systemic treatment effect on study results
- patients who enrolled other clinical study
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03475407
Start Date
March 1 2015
End Date
December 1 2018
Last Update
March 23 2018
Active Locations (1)
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1
Nune Eye Hospital
Seoul, South Korea, 135-280