UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012724 |
|---|---|
| Receipt number | R000014609 |
| Scientific Title | The switching therapy with Ranibizumab for Exudative Age-related Macular Degeneration resistant to Aflibercept |
| Date of disclosure of the study information | 2013/12/30 |
| Last modified on | 2013/12/29 14:43:43 |
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Basic information
Public title
The switching therapy with Ranibizumab for Exudative Age-related Macular Degeneration resistant to Aflibercept
Acronym
The switching therapy with Ranibizumab for Exudative Age-related Macular Degeneration resistant to Aflibercept
Scientific Title
The switching therapy with Ranibizumab for Exudative Age-related Macular Degeneration resistant to Aflibercept
Scientific Title:Acronym
The switching therapy with Ranibizumab for Exudative Age-related Macular Degeneration resistant to Aflibercept
Region
| Japan |
Condition
Condition
Exudative Age-related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the clinical efficacy that switch treatment with ranibizumab for exudative age-related macular degeneration resistant to Aflibercept judged by opthalmologist .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients in the maintenance or improvement in visual acuity 6 months after ranibizumab therapy
Key secondary outcomes
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, fundus autofluorescence
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
lucentis
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Willingness to provide written informed consent
2)BCVA: 0.1-1.0
3)AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
4)outpatient
5)In spite of performing medical treatment by eylea six months or more, it corresponds to a or b.
a:There is no improvement of eyesight as compared with just before the medical treatment start by eylea.(0.3 or more logMAR conversion )
b:Even if it prescribes eylea for the patient 3 times or more, even when exudation is slight at OCT, it recurs to less than residual 3 month.
Key exclusion criteria
1)Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2)Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
3)Prior treatment with photodynamic therapy
4)Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5)Active intraocular inflammation
6)Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7)Patient who the doctor in charge judges are ineligible for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Kobayashi |
Organization
Kagawa university faculty of medicine
Division name
Department of Ophthalmology
Zip code
Address
1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
TEL
087-891-2211
m3k2b1y4@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Kobayashi |
Organization
Kagawa university faculty of medicine
Division name
Department of Ophthalmology
Zip code
Address
1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
TEL
087-891-2211
Homepage URL
m3k2b1y4@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kagawa university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 12 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | 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
| 2013 | Year | 12 | Month | 29 | Day |
Last modified on
| 2013 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014609
