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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015073
Receipt No. R000017536
Scientific Title Intravitreal ranibizumab for patients with neovascular age-related macular degeneration with good baseline visual acuity
Date of disclosure of the study information 2014/09/09
Last modified on 2014/09/09

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Basic information
Public title Intravitreal ranibizumab for patients with neovascular age-related macular degeneration with good baseline visual acuity
Acronym Intravitreal ranibizumab for patients with neovascular AMD with good baseline VA
Scientific Title Intravitreal ranibizumab for patients with neovascular age-related macular degeneration with good baseline visual acuity
Scientific Title:Acronym Intravitreal ranibizumab for patients with neovascular AMD with good baseline VA
Region
Japan

Condition
Condition neovascular age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To report the 1-year results of intravitreal ranibizumab injections for neovascular age-related macular degeneration in patients with good baseline visual acuity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes best-corrected visual acuities
Key secondary outcomes central retinal thickness

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravitreal ranibizumab
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 1) diagnosed with neovasulular AMD by OCT
2) baseline logMAR BCVA of 0.22 or better
Key exclusion criteria 1) the patients who were undergone previous treatment such aslaser photocoagulation, intravitreal triamcinolone, intravitreal anti VEGF or photodynamic therapy.
2) the patients who were undergone vitrectomy
3) the patients who has allergy for fluorescein and indocyanine green
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Ogura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho, Nagoya
TEL 052-853-8251
Email akikato@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aki Kato
Organization Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho, Nagoya
TEL 052-853-8251
Homepage URL
Email akikato@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization none
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
2014 Year 09 Month 09 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
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 10 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
2014 Year 09 Month 06 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017536

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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