UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003854 |
|---|---|
| Receipt number | R000004637 |
| Scientific Title | Proteomic analyses of regulating factors of neovascular ocular inflammation and retinal edema |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2014/01/02 13:22:39 |
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Basic information
Public title
Proteomic analyses of regulating factors of neovascular ocular inflammation and retinal edema
Acronym
Proteome of neovascular ocular inflammation and retinal edema
Scientific Title
Proteomic analyses of regulating factors of neovascular ocular inflammation and retinal edema
Scientific Title:Acronym
Proteome of neovascular ocular inflammation and retinal edema
Region
| Japan |
Condition
Condition
Diabetic retinopathy, Retinal vein occlusion, Retinal artery occlusion, Age-related macular degeneration, Neovascular maculopathy, Neovascular glaucoma, Macula edema, Uveitis, Glaucoma, Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for therapeutic candidate molecules for ocular neovascularization-related diseases and retinal edema and evaluate their association with disease parameters
Basic objectives2
Others
Basic objectives -Others
To evaluate inflammatory cytokine levels and proteome of aqueous humor of patients before and after treatment and assess their association with the disease parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Inflammatory cytokine levels and proteome of aqueous humor of patients before and after treatment (including 1 month after treatment), and clinical parameters including visual acuity, findings from retinal tomography and angiography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Anti-VEGF antibody treatment (Ranibizmab or Bevacizumab)
Interventions/Control_2
Anti-VEGF antibody treatment (Ranibizmab or Bevacizumab), followed by photodynamic therapy
Interventions/Control_3
No treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eyes which require anti-VEGF therapy or surgical intervention
Key exclusion criteria
Eyes with laser coagulation and photodynamic therapy within the past 5 months, and intraocular surgery including cataract surgery in the study eye within the past 5 months.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Inoue |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago Tottori 683-8504, Japan
TEL
+81-859-38-6617
yoinoue@grape.med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Miyazaki |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago Tottori 683-8504, Japan
TEL
+81-859-38-6617
Homepage URL
dm@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Education, Science, and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ideta Eye Hospital
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
鳥取大医学部附属病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Last modified on
| 2014 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004637
