UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005584 |
|---|---|
| Receipt number | R000006212 |
| Scientific Title | Analysis of genotypes associated with the treatment effects of Lucentis for age-related macular degeneration |
| Date of disclosure of the study information | 2011/05/16 |
| Last modified on | 2016/12/09 15:55:48 |
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Basic information
Public title
Analysis of genotypes associated with the treatment effects of Lucentis for age-related macular degeneration
Acronym
ANGEL study
Scientific Title
Analysis of genotypes associated with the treatment effects of Lucentis for age-related macular degeneration
Scientific Title:Acronym
ANGEL study
Region
| Japan |
Condition
Condition
age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Searching for genetic polymorphisms associated with the prognosis after Ranibizumab treatment for age-related macular degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity change at 12 months after the first treatment
Key secondary outcomes
disappearance of retinal exudative change at 3 months, visual acuity change at 3 months, interval for additional treatment, and number of treatment during 12 months
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
Patients receive three monthly intravitreal injections of ranibiumab (0.5mg) and followed up monthly for 12 months. Repeat injections were given to patients who showed insufficient effects of treatment or recurrence.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Treatment naive active angiographically subfoveal choroidal neovascularization associated with age-ralated macular degeneration with best corrected visual acuity of 32/40 to 20/400
Key exclusion criteria
Previous treatment with photocoagulation, surgery, photodynamic therapy, Transpupillary thermotherapy, radiation
Subfoveal fibrosis or atrophy
History of vitrectomy
Intraocular surgery within 2 months
CNV in either eye due to other causes, such as ocular histo-plasmosis, trauma, or pathological myopia
Aphakia or absence of the posterior capsule in the study eye unless it resulted from yttrium aluminum garnet (YAG) posterior capsulotomy in association with prior posterior chamber intraocular lens implantation.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagahisa Yoshimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Kawahara, Shogoin, Sakyo, Kyoto, Japan
TEL
075-751-3248
nagaeye@kuhp.kyoto-u.a.cjp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yamashiro |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Kawahara, Shogoin, Sakyo, Kyoto, Japan
TEL
075-751-3248
Homepage URL
yamashro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Ophthalmology and Visual Sciences
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
福島県立医科大学（福島）、群馬大学（群馬）山梨大学（山梨）、埼玉医科大学（埼玉）、東京医療センター（東京）、東京大学（東京）、名古屋大学（名古屋）、名古屋市立大学（名古屋）、京都大学（京都）、関西医科大学眼科（大阪）、大阪大学（大阪）、神戸大学（神戸）、島根大学（島根）、大塚眼科病院（北海道）、聖隷浜松病院（静岡）、宮田眼科医院（宮崎）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 16 | 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
| 2011 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006212
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/09 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/12/09 | 仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/12/09 | 研究症例.docx |
