The Effects of Intravitreal Ozurdex Implant in DME

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nune Eye Hospital, Seoul, Korea
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

• Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)

• Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation

• Diabetic patients with cystoids macular edema

• Minimum central thickness on OCT not less than 300 microns

• BCVA 20/30~20/320

Exclusion Criteria:

• Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months

• Patients with history of ocular hypertension or glaucoma

• Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT

• Patients with macular ischemia on FFA

• Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva

• Patients whose posterior lens capsule is not intact.

• patients with known hypersensitivity to any components of this product.

• patients with vitreous hemorrhage

• patients who have systemic treatment effect on study results

• patients who enrolled other clinical study