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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021589
Receipt No. R000023567
Scientific Title The effect of anti-VEGF treatments for neovascular,exudative and inflammatory ocular diseases
Date of disclosure of the study information 2016/04/01
Last modified on 2016/10/04

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Basic information
Public title The effect of anti-VEGF treatments for neovascular,exudative and inflammatory ocular diseases
Acronym The ocular effect of anti-VEGF treatments
Scientific Title The effect of anti-VEGF treatments for neovascular,exudative and inflammatory ocular diseases
Scientific Title:Acronym The ocular effect of anti-VEGF treatments
Region
Japan

Condition
Condition Ocular diseases including neovascular, serous and inflammatory diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the availability and safety of intravitreal anti-VEGF drugs. We also evaluate the aqueous humor and vitreous sample in eyes, which received anti-VEGF drugs and no such drugs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual prognosis including visual acuity after intravitreal anti-VEGF drugs
Key secondary outcomes The intraocular inflammatory mediators including cytokines and chemokines
The intraocular metabolomic profile including reactive polysulfide species.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravitreal anti-VEGF drugs (less than 2.0mg)

Cataract and vitreous surgery
Interventions/Control_2 Control
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 Exudative or inflammatory ocular diseases including uveitis, macular diseases, retinal detachment, glaucoma, corneal diseases.
Key exclusion criteria Children, and adults who can not understand this study or do not have a consciousness.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru nakazawa
Organization Tohoku university graduate School of Medicine
Division name The department of ophthalmology
Zip code
Address Sendai, Japan, 1-1 Seiryo-machi, Aoba-ku
TEL 0227177294
Email ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiko Nitta
Organization Tohoku university graduate School of Medicine
Division name The department of ophthalmology
Zip code
Address Sendai, Japan, 1-1 Seiryo-machi, Aoba-ku
TEL 0227177294
Homepage URL
Email nitta@oph.med.tohoku.ac.jp

Sponsor
Institute The department of ophthalmology,Tohoku university graduate School of Medicine
Institute
Department

Funding Source
Organization The department of ophthalmology,Tohoku university graduate 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 Enrolling by invitation
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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
2016 Year 03 Month 23 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023567

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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