search
Back to results

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

Primary Purpose

Diabetes Mellitus, Macular Edema, Retinal Exudates and Deposits

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal dexamethasone 0.7mg implant
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes mellitus, macular edema, hard exudate, intravitreal injections, dexamethasone, implant

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gyeongsang National University HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Dong-A University hospitalRecruiting
  • Pusan national university hospitalRecruiting
  • Inje University Haeundae Paik hospitalRecruiting
  • Inje University Busan Paik hospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal dexamethasone implant

Arm Description

Intravitreal dexamethasone 0.7mg implant (Ozurdex)

Outcomes

Primary Outcome Measures

The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2015
Last Updated
April 2, 2015
Sponsor
Inje University
Collaborators
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT02399657
Brief Title
Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema
Official Title
A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Macular Edema, Retinal Exudates and Deposits
Keywords
diabetes mellitus, macular edema, hard exudate, intravitreal injections, dexamethasone, implant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intravitreal dexamethasone implant
Arm Type
Experimental
Arm Description
Intravitreal dexamethasone 0.7mg implant (Ozurdex)
Intervention Type
Drug
Intervention Name(s)
Intravitreal dexamethasone 0.7mg implant
Other Intervention Name(s)
Ozurdex injection
Intervention Description
Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata
Primary Outcome Measure Information:
Title
The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
Time Frame
after 12 months
Secondary Outcome Measure Information:
Title
The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity
Time Frame
after 12 months
Title
The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)
Time Frame
after 12 months
Title
The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography
Time Frame
after 12 months
Title
The average change in number of microaneurysm in macula
Time Frame
after 12 months
Title
The progression rate of cataract
Time Frame
for 12 months
Title
Number of eyes having increased intraocular pressure
Time Frame
for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40) Those who have a central macular thickness on OCT over 300 micrometer 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: Those who have CSME without hard exudates 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) Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months Those who have a visual acuity of contralateral eye less than 0.1 (10/100) Those who received focal laser treatment on macula within 3 months Those who had intravitreal anti-VEGF agent injection within 3 months Those who had intravitreal triamcinolone injection within 6 months Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center) Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease) Those who refuse to submit written consent Those who cannot understand the contents of the clinical study and cooperate in the clinical trial Those who are pregnant or lactating women Those who have a history of vitrectomy Those who require systemic corticosteroid or immunosuppressive agent treatment 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Woong Kim, M.D.
Phone
82-51-890-8997
Email
maekbak@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Ki Yoon, M.D.
Phone
82-51-890-8707
Email
syst18@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Woong Kim, M.D.
Organizational Affiliation
Inje University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ji Eun Lee, M.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joo Eun Lee, M.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Jin Jeung, M.D.
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Joon Lee, M.D.
Organizational Affiliation
Kosin University Gospel Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
In Young Chung, M.D.
Organizational Affiliation
Gyeongsang National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Pil Shin, M.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Hyok Chang, M.D.
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyeongsang National University Hospital
City
Jinju
State/Province
Gyeongsangnam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Young Chung, M.D.
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Joon Lee, M.D.
Facility Name
Dong-A University hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Jin Jeung, M.D.
Facility Name
Pusan national university hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Eun Lee, M.D.
Facility Name
Inje University Haeundae Paik hospital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Eun Lee, M.D.
Facility Name
Inje University Busan Paik hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Woong Kim, M.D.
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Pil Shin, M.D.
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Hyok Chang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19171208
Citation
Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.
Results Reference
background
PubMed Identifier
7831044
Citation
Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995 Jan;102(1):7-16. doi: 10.1016/s0161-6420(95)31052-4.
Results Reference
background
PubMed Identifier
8366922
Citation
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Results Reference
background
PubMed Identifier
2866759
Citation
Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
Results Reference
background
PubMed Identifier
20212197
Citation
Haller JA, Kuppermann BD, Blumenkranz MS, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010 Mar;128(3):289-96. doi: 10.1001/archophthalmol.2010.21.
Results Reference
background
PubMed Identifier
33451297
Citation
Yoon CK, Sagong M, Shin JP, Lee SJ, Lee JE, Lee JE, Chung I, Jeong WJ, Pak KY, Kim HW. Title: efficacy of intravitreal dexamethasone implant on hard exudate in diabetic macular edema. BMC Ophthalmol. 2021 Jan 15;21(1):41. doi: 10.1186/s12886-020-01786-2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs