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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Diabetes Mellitus Macular Edema Retinal Exudates and Deposits

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal dexamethasone implant

Intravitreal dexamethasone 0.7mg implant (Ozurdex)

Group Type EXPERIMENTAL

Intravitreal dexamethasone 0.7mg implant

Intervention Type DRUG

Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata

Interventions

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Intravitreal dexamethasone 0.7mg implant

Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata

Intervention Type DRUG

Other Intervention Names

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Ozurdex injection

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
2. Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
3. Those who have a central macular thickness on OCT over 300 micrometer
4. 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

1. Those who have CSME without hard exudates
2. 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)
3. Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months
4. Those who have a visual acuity of contralateral eye less than 0.1 (10/100)
5. Those who received focal laser treatment on macula within 3 months
6. Those who had intravitreal anti-VEGF agent injection within 3 months
7. Those who had intravitreal triamcinolone injection within 6 months
8. Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
9. Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)
10. Those who refuse to submit written consent
11. Those who cannot understand the contents of the clinical study and cooperate in the clinical trial
12. Those who are pregnant or lactating women
13. Those who have a history of vitrectomy
14. Those who require systemic corticosteroid or immunosuppressive agent treatment
15. 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No