The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor

Nune Eye Hospital, Seoul, Korea1 site in 1 country20 target enrollmentMarch 2015

ConditionsDiabetic Macular Edema

InterventionsOzurdex intravitreal injection

DrugsOzurdex intravitreal injection

Overview

Phase: Phase 4
Intervention: Ozurdex intravitreal injection
Conditions: Diabetic Macular Edema
Sponsor: Nune Eye Hospital, Seoul, Korea
Enrollment: 20
Locations: 1
Primary Endpoint: Changes of Central foveal thickness(CFT, height in micrometers)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nune Eye Hospital, Seoul, Korea

Responsible Party

Principal Investigator

Oh Woong Kwon

Chief of retina center in Nune Eye Hospital

Nune Eye Hospital, Seoul, Korea

Eligibility 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

Arms & Interventions

Treatment Group

Ozurdex intravitreal injection

Intervention: Ozurdex intravitreal injection

Outcomes

Primary Outcomes

Changes of Central foveal thickness(CFT, height in micrometers)

Time Frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

Secondary Outcomes

Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)(Baseline, 6 weeks, 18 weeks)
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)(Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks)