The Effects of Intravitreal Ozurdex Implant in DME

March 22, 2018 updated by: Oh Woong Kwon, Nune Eye Hospital, Seoul, Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-280
        • Recruiting
        • Nune Eye Hospital
        • Contact:
        • Principal Investigator:
          • Oh Woong Kwon, MD, Ph D
        • Sub-Investigator:
          • Jin Hae Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Ozurdex intravitreal injection
Drug: Ozurdex intravitreal injection
  1. Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline
  2. AC paracentesis at 6 wk
  3. intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of Central foveal thickness(CFT, height in micrometers)
Time Frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nune Eye Hospital, Seoul, Korea

Investigators

  • Principal Investigator: Oh Woong Kwon, MD PhD, Nune Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRBF004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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