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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022574
Receipt No. R000026018
Scientific Title Survey of topical and systemic therapy for advanced endogenous uveitis
Date of disclosure of the study information 2016/06/02
Last modified on 2017/06/03

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Basic information
Public title Survey of topical and systemic therapy for advanced endogenous uveitis
Acronym Survey of therapy for endogenous uveitis
Scientific Title Survey of topical and systemic therapy for advanced endogenous uveitis
Scientific Title:Acronym Survey of therapy for endogenous uveitis
Region
Japan

Condition
Condition endogenous uveitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate treatment contents for advanced endogenous uveitis, target disease of treatment, and primary ophthalmic findings.
Basic objectives2 Others
Basic objectives -Others Retrospectively observational multicenter study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Treatment contents for advanced endogenous uveitis.
Key secondary outcomes 1. Target disease of treatment
2. Primary ophthalmic findings

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Endogenous uveitis
Key exclusion criteria Infectious and other exogenous uveitis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Takeuchi
Organization National Defense Medical College
Division name Department of Ophthalmology
Zip code
Address 3-2 Namiki, Tokorozawa-shi, Saitama-ken 359-8513, Japan
TEL 04-2995-1511
Email masatake@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Takeuchi
Organization National Defense Medical College
Division name Department of Ophthalmology
Zip code
Address 3-2 Namiki, Tokorozawa-shi, Saitama-ken 359-8513, Japan
TEL 04-2995-1511
Homepage URL
Email masatake@ndmc.ac.jp

Sponsor
Institute Department of Ophthalmology, National Defense Medical College
Institute
Department

Funding Source
Organization Department of Ophthalmology, National Defense Medical College
Organization
Division
Category of Funding Organization Other
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 06 Month 02 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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2017 Year 05 Month 09 Day

Other
Other related information Investigative data of patients with advanced endogenous uveitis are as follows:
1. Date and time that the disease has worsened
2. The name of a disease
3. Affected eye (lateral or bilateral)
4. Corrected visual acuity before the disease was worse
5. Corrected visual acuity at the time the disease was worse
6. Primary ophthalmic findings
7. Treatment contents

Management information
Registered date
2016 Year 06 Month 01 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026018

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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