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

Phase 4

• Conditions: Retinal Exudates and Deposits; Diabetes Mellitus; Macular Edema
• Interventions: Drug: Intravitreal dexamethasone 0.7mg implant

• Registration Number: NCT02399657
• Lead Sponsor: Inje University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal dexamethasone implant	Intravitreal dexamethasone 0.7mg implant	Intravitreal dexamethasone 0.7mg implant (Ozurdex)

Primary Outcome Measures

Name	Time	Method
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)	after 12 months

Secondary Outcome Measures

Name	Time	Method
The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity	after 12 months
The average change in number of microaneurysm in macula	after 12 months
The progression rate of cataract	for 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
Number of eyes having increased intraocular pressure	for 12 months

Trial Locations

Locations (8)

Gyeongsang National University Hospital; 🇰🇷 Jinju, Gyeongsangnam-do, Korea, Republic of

Dong-A University hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik hospital; 🇰🇷 Busan, Korea, Republic of

Pusan national university hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Haeundae Paik hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of