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Change of Macular Pigment Optical Density After Intravitreal Triamcinolon Injection Treatment in Patient with Diabetic Macular Edema

Status Approved

  • First Submitted Date

    2019/08/05

  • Registered Date

    2019/08/21

  • Last Updated Date

    2022/01/07

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004230
    Unique Protocol ID KC18MESI0717
    Public/Brief Title Change of Macular Pigment Optical Density After Intravitreal Triamcinolon Injection Treatment
    Scientific Title Change of Macular Pigment Optical Density After Intravitreal Triamcinolon Injection Treatment in Patient with Diabetic Macular Edema
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KC18MESI0717
    Approval Date 2019-05-24
    Institutional Review Board Name Institutional Review Board, The Catholic university of Korea
    Institutional Review Board Address 222, Banpo-daero, Seocho-gu, Seoul
    Institutional Review Board Telephone 02-2258-8212
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young-Hoon Park
    Title Professor
    Telephone +82-2-2258-6349
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
    Contact Person for Public Queries
    Name Rae-Young Kim
    Title Clnical fellow
    Telephone +82-2-2258-6349
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
    Contact Person for Updating Information
    Name Rae-Young Kim
    Title Clnical fellow
    Telephone +82-2-2258-6349
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2022-02-28 Anticipated
    Target Number of Participant 62
    Primary Completion Date 2022-04-24 , Anticipated
    Study Completion Date 2022-04-24 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2022-02-28 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hanmi Pharm
    Organization Type Pharmaceutical Company
    Project ID 심사중
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Diabetic macular edema is a major cause of vision threats in pateints with diabetes, and diabetic macular edema is known to affect the macular structure. Macular pigments helps maintain the function of retina by removing free radical or blocking off harmful light to the eyes, and its density is decreased with age. Previous studies have shown that macular pigment optical density is reduced in type 2 diabetic retinopathy, but effect of diabetic macular edema on macular pigment optic density density is not well understood.
    In this study, we intended to observe change of macular pigment optical density using device called MPS II(Macular Pigment Optical Density , MPOD, MPS II) between before and after intravitreal triamcinolone (MaQaid®, Wakamoto Pharmaceutical Co., Lt).d., Tokyo, Japan) injection in diabetic macular edema
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Basic Science
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description
    Patient with diabetic macular edmea who needs treatment
    Triamcinolone acetonide(MaQaid®, Wakamoto Pharmaceutical Co., Ltd., Tokyo, Japan)/dosage 0.1 mL/Single injection/Intravitreal injection
    Number of Arms 1
    Arm 1

    Arm Label

    Treatment group

    Target Number of Participant

    62

    Arm Type

    Experimental

    Arm Description

    Patient with diabetic macular edmea who needs treatment
    Triamcinolone acetonide(MaQaid®, Wakamoto Pharmaceutical Co., Ltd., Tokyo, Japan)/dosage 0.1 mL/Single injection/Intravitreal injection
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H35.80)Retinal oedema 

    Macular edema
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    1. A person who meets the following criteria
    (1) a person diagnosed with diabetic and macular edema
    (2) inovolved at least one eye
    (3) central macular thickness is 300 or more by optical coherence tomography
    2. Adult, the age of twenty or more
    3. Patients with visual acuity less than or equal to 20/40 (Snellen) in the pathologic eye
    4. Patients who voluntarily decided to participate in the study and signed a consent form
    Exclusion Criteria
    1. Pregnant state
    2. Previous vitrectomy history
    3. Previous history of intravitreal triamcinolone injection due to diabetic macular edema
    4. Macular edema caused by other than diabetes
    5. Diagnosed or treatment for other ocular cormorbidity such as, Intermediate or advanced dry age related macular degeneration (ARMD), exudative ARMD, vitreous hemorrhage, retinal vein occlusion, uveitis, retinal dystrophy, ocular trauma, optic nerve atrophy, intraocular tumor, corneal opacity
    6. Ongoing diagnosed or suspcious intraocular or periocular infection
    7. Uncontrolled glaucoma, Intraocular pressure over 21mmHg even with appropriate use of intraocular pressure lowering agents. History of glaucoma surgery due to steroid induced glaucoma
    8. Chronic alcoholics or psychiatric state that could affact the study process.
    9. Patients who thought to be not able to complete study process or have a medical condition is unsuitable for study process by clinicion's opinion
    10. Uptaking lutein or other medication which affect macular pigment optical density.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    macular pigment optical density(MPOD) after 4, 12 weeks from intravitreal injection
    Timepoint
    After 4, 12 weeks from intravitreal injection
    Secondary Outcome(s) 1
    Outcome
    Central macular thickness
    Timepoint
    After 4, 12 weeks from intravitreal injection
    Secondary Outcome(s) 2
    Outcome
    best corrected visual acuity
    Timepoint
    After 4, 12 weeks from intravitreal injection
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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