UMIN-CTR Clinical Trial

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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