UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021244 |
|---|---|
| Receipt number | R000024507 |
| Scientific Title | Aqueous cytokines as predictors of the recurrence of macular edema after Anti-Vascular Endothelial Growth Factor and steroid therapy in diabetic. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/03/03 21:01:24 |
* 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
Aqueous cytokines as predictors of the recurrence of macular edema after Anti-Vascular Endothelial Growth Factor and steroid therapy in diabetic.
Acronym
Aqueous cytokines as predictors of the recurrence of macular edema in diabetic.
Scientific Title
Aqueous cytokines as predictors of the recurrence of macular edema after Anti-Vascular Endothelial Growth Factor and steroid therapy in diabetic.
Scientific Title:Acronym
Aqueous cytokines as predictors of the recurrence of macular edema in diabetic.
Region
| Japan |
Condition
Condition
Diabetic macula edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the aqueous cytokines as predictors after Anti-Vascular Endothelial Growth Factor and steroid therapy for diabetic macular edema in diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of VEGF, IP-10, MCP-1, IL-1Beta, IL-6, IL-8, IL-1 and IL-12 in the aqueous humor
Key secondary outcomes
Central macular thickness, Flare
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Local administration of Anti-Vascular Endothelial Growth Factor or steroid until improvement in macula edema
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with diabetic macula edema
Patients with pseudophakic eye
Patients who agree in writing to participate in this study after enough explanation.
Key exclusion criteria
Patients with phakic eye
Patients who are going to undergo other intraocular surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Gozawa |
Organization
University of Fukui, Faculty of Medical Sciences
Division name
Department of Ophthalmology
Zip code
Address
23-3 Shimoaiduki, Matsuoka, Eiheiji, Yosida Fukui
TEL
0776618403
makoto.gozawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Gozawa |
Organization
University of Fukui. Faculty of Medical Sciences
Division name
Department of Ophthalmology
Zip code
Address
23-3 Shimoaiduki, Matsuoka, Eiheiji, Yosida Fukui
TEL
0776618403
Homepage URL
makoto.gozawa@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
none
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
福井大学医学部附属病院
東京医科大学八王子医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024507
