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The Effects of Intravitreal Ozurdex Implant in DME

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ozurdex intravitreal injection
Sponsored by
Nune Eye Hospital, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, cytokine, dexamethasone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nune Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Ozurdex intravitreal injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)

Full Information

First Posted
April 14, 2015
Last Updated
March 22, 2018
Sponsor
Nune Eye Hospital, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03475407
Brief Title
The Effects of Intravitreal Ozurdex Implant in DME
Official Title
The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nune Eye Hospital, Seoul, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic macular edema, cytokine, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Ozurdex intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Ozurdex intravitreal injection
Intervention Description
Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline AC paracentesis at 6 wk intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk
Primary Outcome Measure Information:
Title
Changes of Central foveal thickness(CFT, height in micrometers)
Time Frame
Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)
Time Frame
Baseline, 6 weeks, 18 weeks
Title
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)
Time Frame
Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Woong Kwon, MD, Ph D
Phone
+82+2+2086+7752
Email
owkwon0301@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Woong Kwon, MD PhD
Organizational Affiliation
Nune Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nune Eye Hospital
City
Seoul
ZIP/Postal Code
135-280
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Hae Lee, MD
Phone
+82-10-2765-5303
Email
seastar01@hanmail.net
First Name & Middle Initial & Last Name & Degree
Oh Woong Kwon, MD, Ph D
First Name & Middle Initial & Last Name & Degree
Jin Hae Lee, MD

12. IPD Sharing Statement

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The Effects of Intravitreal Ozurdex Implant in DME

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