UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021642 |
|---|---|
| Receipt number | R000024957 |
| Scientific Title | How to prevent vascular infarction due to anti-VEGF treatment for DME |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2017/04/07 05:58:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
How to prevent vascular infarction due to anti-VEGF treatment for DME
Acronym
Vascular infarction due to anti-VEGF treatment for DME
Scientific Title
How to prevent vascular infarction due to anti-VEGF treatment for DME
Scientific Title:Acronym
Vascular infarction due to anti-VEGF treatment for DME
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the value of bio markers which reflects vascular infarction during anti VEGF treatment for diabetic macular edema (DME).
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of various cytokines
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Type I and II DM patients over 20 yrs old with IC.
2)Clinically Significant Macular Edema (CSME) with diffuse macular edema which cannnot treat only with photocoagulation (PC).
3)VA disturbances not due to diabetic retinopathy but DME.
4)LogMAR BCVA between 1.52 and 1.22.
5)Central mretinal thickness >300 micro meter within 1mm of OCT retinal map..
Key exclusion criteria
1)Received PC treatment within 3 months.
2)Ischemic maculopathy.
3)Vitreo-macular traction syndrome.
4)Active diabetic retinopathy.
5)Any history of glaucoma.
6)Any history of optic neuropathy,
7)Any history of vitrectomy,
8)Vitreal or sub-tenon injections within 3 months before treatment.
10) Cataract surgery within 6 months before treatment.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology,Mie University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology,Mie University, School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During loading phase of intravitreal injection of anti-VEGF drug(monthly),we collect anterior chamber fluid and blood from patients at 1)pre-treatment, 1w after treatment (only blood) and 3)at 2nd injection of anti-VEGF drug.
Concentration of various cytokines are evaluated from collected samples.
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024957
