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
CRIS Registration Number |
KCT0004230 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Hanmi Pharm |
Organization Type | Pharmaceutical Company |
Project ID | 심사중 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, Seoul St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
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 |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H35.80)Retinal oedema Macular edema |
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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)
Type of Primary Outcome | Not applicable | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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