The Effects of Intravitreal Ozurdex Implant in DME

Nune Eye Hospital, Seoul, Korea

Status and phase

Unknown

Phase 4

Conditions

Diabetic Macular Edema

Treatments

Drug: Ozurdex intravitreal injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03475407

CRBF004

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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