Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema

Study Overview
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Brief Summary
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A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.

Detailed Description
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Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.

Official Title
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A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema

Conditions
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Diabetes Mellitus, Macular Edema, Retinal Exudates and Deposits

Intervention / Treatment
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* Drug: Intravitreal dexamethasone 0.7mg implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40) Those who have a central macular thickness on OCT over 300 micrometer If both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than Ozurdex or focal laser photocoagulation, anti-VEGF (vascular endothelial growth factor) injection is not allowed in contralateral eye) Exclusion Criteria: Those who have CSME without hard exudates Those who have macular edema not related with diabetic retinopathy (e.g. AMD (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension) Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months Those who have a visual acuity of contralateral eye less than 0.1 (10/100) Those who received focal laser treatment on macula within 3 months Those who had intravitreal anti-VEGF agent injection within 3 months Those who had intravitreal triamcinolone injection within 6 months Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center) Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease) Those who refuse to submit written consent Those who cannot understand the contents of the clinical study and cooperate in the clinical trial Those who are pregnant or lactating women Those who have a history of vitrectomy Those who require systemic corticosteroid or immunosuppressive agent treatment Those who are banned from using Ozurdex Ocular infection or periocular infection Advanced glaucoma Hypersensitivity to dexamethasone or other component of Ozurdex Posterior lens capsule rupture or Aphakia Anterior chamber intraocular lens or posterior capsule rupture

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

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: Intravitreal dexamethasone implant<br>Intravitreal dexamethasone 0.7mg implant (Ozurdex) | Drug: Intravitreal dexamethasone 0.7mg implant<br>* Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata<br>* Other names: Ozurdex injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center) |  | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity |  | after 12 months | 
| The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography) |  | after 12 months | 
| The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography |  | after 12 months | 
| The average change in number of microaneurysm in macula |  | after 12 months | 
| The progression rate of cataract |  | for 12 months | 
| Number of eyes having increased intraocular pressure |  | for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, macular edema, hard exudate, intravitreal injections, dexamethasone, implant