UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010735 |
|---|---|
| Receipt number | R000012547 |
| Scientific Title | Comparison of aquous humor and serum VEGF concentration in patients with and without eye diseases |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2013/05/16 08:39:24 |
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Basic information
Public title
Comparison of aquous humor and serum VEGF concentration in patients with and without eye diseases
Acronym
Comparison of aquous humor and serum VEGF concentration
Scientific Title
Comparison of aquous humor and serum VEGF concentration in patients with and without eye diseases
Scientific Title:Acronym
Comparison of aquous humor and serum VEGF concentration
Region
| Japan |
Condition
Condition
Age related macula degeneration,Diabetic retinopthy, Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare aqueous humor and serum levels of vascular endothelial growth factor in patients with and without eye disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum levels of VEGF
aqueous humor levels of VEGF
Key secondary outcomes
serum levels of inflammatory cytokine
aqueous humor levels of inflammatory cytokine
vitreous levels of VEGF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
with injection of anti-VEGF agent
Interventions/Control_2
without injection of anti-VEGF agent
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
Having age related macula degeneration, diabetic retinopathy and retinal vein occlusion
Key exclusion criteria
patients who don't agree this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Murata |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL
0263-37-2664
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Hirano |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL
Homepage URL
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 05 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 16 | Day |
Last modified on
| 2013 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012547
