The Effects of Intravitreal Ozurdex Implant in DME

Study Overview
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Brief Summary
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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 DME patients.

Official Title
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The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Ozurdex intravitreal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Ozurdex intravitreal injection | Drug: Ozurdex intravitreal injection<br>* Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline AC paracentesis at 6 wk intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Central foveal thickness(CFT, height in micrometers) |  | Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1) |  | Baseline, 6 weeks, 18 weeks | 
| Changes of Best corrected Visual acuity(BCVA, ETDRS scale) |  | Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, cytokine, dexamethasone