Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema

April 2, 2015 updated by: Hyun Woong Kim, Inje University

A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema

A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.

Study Type

Interventional

Enrollment (Anticipated)

48

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 Contact Backup

  • Name: Chang Ki Yoon, M.D.
  • Phone Number: 82-51-890-8707
  • Email: syst18@gmail.com

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University Hospital
        • Contact:
          • Woo Jin Jeung, M.D.
      • Busan, Korea, Republic of, 602-739
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Ji Eun Lee, M.D.
      • Busan, Korea, Republic of, 612-030
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
          • Joo Eun Lee, M.D.
      • Busan, Korea, Republic of, 602-702
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
          • Sang Joon Lee, M.D.
      • Busan, Korea, Republic of, 614-735
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Hyun Woong Kim, M.D.
      • Daegu, Korea, Republic of, 700-721
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Jae Pil Shin, M.D.
      • Daegu, Korea, Republic of, 705-717
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Woo Hyok Chang, M.D.
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
          • In Young Chung, M.D.

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
  2. Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
  3. Those who have a central macular thickness on OCT over 300 micrometer
  4. If both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than Ozurdex or focal laser photocoagulation, anti-VEGF (vascular endothelial growth factor) injection is not allowed in contralateral eye)

Exclusion Criteria:

  1. Those who have CSME without hard exudates
  2. Those who have macular edema not related with diabetic retinopathy (e.g. AMD (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)
  3. Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months
  4. Those who have a visual acuity of contralateral eye less than 0.1 (10/100)
  5. Those who received focal laser treatment on macula within 3 months
  6. Those who had intravitreal anti-VEGF agent injection within 3 months
  7. Those who had intravitreal triamcinolone injection within 6 months
  8. Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
  9. Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)
  10. Those who refuse to submit written consent
  11. Those who cannot understand the contents of the clinical study and cooperate in the clinical trial
  12. Those who are pregnant or lactating women
  13. Those who have a history of vitrectomy
  14. Those who require systemic corticosteroid or immunosuppressive agent treatment

  15. Those who are banned from using Ozurdex

    • Ocular infection or periocular infection
    • Advanced glaucoma
    • Hypersensitivity to dexamethasone or other component of Ozurdex
    • Posterior lens capsule rupture or Aphakia
    • Anterior chamber intraocular lens or posterior capsule rupture

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: Intravitreal dexamethasone implant
Intravitreal dexamethasone 0.7mg implant (Ozurdex)
Drug: Intravitreal dexamethasone 0.7mg implant
Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata
Other Names:
  • Ozurdex injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
Time Frame: after 12 months
after 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity
Time Frame: after 12 months
after 12 months
The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)
Time Frame: after 12 months
after 12 months
The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography
Time Frame: after 12 months
after 12 months
The average change in number of microaneurysm in macula
Time Frame: after 12 months
after 12 months
The progression rate of cataract
Time Frame: for 12 months
for 12 months
Number of eyes having increased intraocular pressure
Time Frame: for 12 months
for 12 months

Collaborators and Investigators

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

Sponsor

Inje University

Collaborators

Allergan

Investigators

  • Study Director: Hyun Woong Kim, M.D., Inje University
  • Principal Investigator: Ji Eun Lee, M.D., Pusan National University Hospital
  • Principal Investigator: Joo Eun Lee, M.D., Inje University
  • Principal Investigator: Woo Jin Jeung, M.D., Dong-A University Hospital
  • Principal Investigator: Sang Joon Lee, M.D., Kosin University Gospel Hospital
  • Principal Investigator: In Young Chung, M.D., Gyeongsang National University Hospital
  • Principal Investigator: Jae Pil Shin, M.D., Kyungpook National University Hospital
  • Principal Investigator: Woo Hyok Chang, M.D., Yeungnam University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXTINCT

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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