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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008588
Receipt No. R000010089
Scientific Title Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization
Date of disclosure of the study information 2012/08/30
Last modified on 2012/08/01

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Basic information
Public title Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization
Acronym Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization
Scientific Title Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization
Scientific Title:Acronym Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization
Region
Europe

Condition
Condition Choroidal neovascularization associated with pathological myopia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to compare the effects of intravitreal ranibizumab (IVR) and intravitreal bevacizumab (IVB) in the treatment of subfoveal choroidal neovascularization (CNV) secondary to pathological myopia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change in mean best-corrected visual acuity (BCVA) and the proportion of eyes improving in BCVA by > 1 and > 3 lines at the 18-month examination.
Key secondary outcomes The changes in mean central macular thickness, the mean number of injections administered in each group, and the change in mean CNV area.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravitreal ranibizumab injection
Interventions/Control_2 Intravitreal bevacizumab injection
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) spherical equivalent refractive error of -6.0 dioptres (D) or more (an eye that had a spherical equivalent less than &#8211;6.0 D was eligible if there were retinal abnormalities consistent with PM, such as lacquer cracks, chorioretinal atrophy or posterior staphyloma, and if the axial length of the eye was at least 26.5 mm); 2) treatment for na&iuml;ve subfoveal myopic CNV; subfoveal location was defined as the presence of CNV under the geometric center of the foveal vascular zone and confirmed on fluorescein angiography (FA); 3) baseline best-corrected visual acuity (BCVA) between 20/32 and 20/400, both inclusive. Only females at least 12 months post menopause or using standard forms of contraception in the fertile age could be included.
Key exclusion criteria 1) intraocular surgery of any kind within six months of the day of injection, 2) any other ocular disease that could compromise vision in the study eye, 3) ocular hypertension or glaucoma 4) uncontrolled systemic hypertension; peripheral vascular disease and history of thromboembolism, ischemic heart disease or stroke.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Francesco Bandello
Organization University Vita-Salute, Scientific Institute San Raffaele
Division name Department of Ophthalmology
Zip code
Address Via Olgettina 60. Milan, Italy, 20132
TEL +81-039226432648
Email

Public contact
Name of contact person
1st name
Middle name
Last name Prof. Francesco Bandello
Organization University Vita-Salute, Scientific Institute San Raffaele
Division name Department of Ophthalmology
Zip code
Address Via Olgettina 60. Milan, Italy, 20132
TEL +81-039226432648
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele
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
2012 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2009 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 01 Day
Last modified on
2012 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010089

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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