UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016152 |
|---|---|
| Receipt number | R000018753 |
| Scientific Title | Multi-Center Study of Aflibercept Therapy for Neovascular Age-Related Macular Degeneration Using Trreat and Extend Strategy |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2015/01/07 20:48:59 |
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Basic information
Public title
Multi-Center Study of Aflibercept Therapy for Neovascular Age-Related Macular Degeneration Using Trreat and Extend Strategy
Acronym
Treat & Extend Stratedy with Aflibercept for AMD
Scientific Title
Multi-Center Study of Aflibercept Therapy for Neovascular Age-Related Macular Degeneration Using Trreat and Extend Strategy
Scientific Title:Acronym
Treat & Extend Stratedy with Aflibercept for AMD
Region
| Japan |
Condition
Condition
Neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the Treat and Extend Strategy with aflibercept for neovascular age-related macular degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in visual acuity during 1-year after aflibercept therapy
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20-year-old or older
2. Neovascular age-related macular degeneration with exudative changes detected by optical coherence tomography
3. No previous treatment history for age-related macular degeneration
4. Agreement with informed consent
Key exclusion criteria
1. Local Steroid Therapy within 3 momths
2. Previous history of anti-VEGF treatments
3. Past history of photodynamic therapy
4. Severe cataract
5. Local or systemic infection
6. Hisrory of uveitis
7. Apahakic eyes
8. Uncontrolled hypertension
9. Cerebrovascular or cardiac vascular accident within 6 months
10. Renal failure requiring dyalisis
11. Allegy for fluorescsin and indocyaningreen dye
12. Pregnancy or lactating
13. Other conditions that the principal investigator points out
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iida Tomohiro |
Organization
Tokyo Women's Medical University
Division name
Ophthalmology
Zip code
Address
8-1 Kawada-cho, Sinjuku-ku, Tokyo
TEL
03-3353-8111
iida@oph.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Koizumi |
Organization
Tokyo Women's Medical University
Division name
Ophthalmology
Zip code
Address
8-1 Kawada-cho, Sinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
koizumi.hideki@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Bayer
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyorin Univeristy
Fukushima Medical University
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
| 2015 | Year | 01 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Patients information: age, gender, diagnosis, past history, laterality, duration of symptoms
2. Subtypes of age-related macular degeneration
3. Fundus photograph
4. Optical coherence tomography
5. Fluorescein angiography
6. Indocyanine green angiography
7. Visual acuity
8. Trreatment courses
9. Adverse events
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018753
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
