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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003854
Receipt No. 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

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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
Email 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
Email dm@grape.med.tottori-u.ac.jp

Sponsor
Institute Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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