NCT02399657

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Macular Edema
• Retinal Exudates and Deposits

Interventions

Type	Name	Description
DRUG	Intravitreal dexamethasone 0.7mg implant	Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-03-26
• Last updated: 2015-04-06

Locations

8 sites across 1 country: South Korea