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

Inje University

Status and phase: Unknown; Phase 4

Conditions: Macular Edema; Diabetes Mellitus; Retinal Exudates and Deposits

Treatments: Drug: Intravitreal dexamethasone 0.7mg implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02399657

EXTINCT

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Intravitreal dexamethasone implant

Experimental group

Description:

Intravitreal dexamethasone 0.7mg implant (Ozurdex)

Treatment:

Drug: Intravitreal dexamethasone 0.7mg implant