UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008588 |
|---|---|
| Receipt number | 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 01:21:43 |
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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 –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 naïve 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
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
Sponsor or person
Institute
Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010089
