UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015810 |
|---|---|
| Receipt number | R000018394 |
| Scientific Title | The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2019/03/28 16:23:47 |
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Basic information
Public title
The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Acronym
The change of retinal sensitivity with IVA for AMD
Scientific Title
The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Scientific Title:Acronym
The change of retinal sensitivity with IVA for AMD
Region
| Japan |
Condition
Condition
wet type age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the visual function from various angle with the analysis of retinal sensitivity after intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change amount of retinal sensitivity at six month from base line after initial therapy of intravitreal injection of aflibercept for wet type of age-related macular degeneration
Key secondary outcomes
1.The ratio of patients with improvement or preservation of visual acuity after intravitreal injection of aflibercept
2.The change amount of visual aquity at 1,3,6,12 months from base line
3.The change amount of central foveal thickness at 1,3,6,12 months from base line
4.The ratio of patients with subretinal or intraretinal exdative change at 6 and 12 months
5.The change amount of retinal sensitivity at 1,3 and 12 months from base line
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients who received informed consent and agreed the investigation
2)man or woman 50 years or older
3)patiens with typical AMD or polypoidal chorodal vasculopathy
4)treatment naive for AMD
5)decimal visual acuity within 0.1 to 1.2
Key exclusion criteria
1.Patients who need to undergo intravitreal injection of aflibercept for their both eyes.
2.The lesion is more than 12 disc diameter area with fluorecein angiography
3.Subretinal hemorrhage with 50 percent or more of the lesion area
4.Subretinal scar or fibrosis with 50 percent or more of the lesion area
5.retinal pigment epithelium tear
6.patients who had past stage 3 or 4 macular hole
7.patients who received the therapy with triamcinolone acetonide within 6 months
8.patients who received the therapy with Dexamethasone within 30 days
9.patients who received intra occular surgery within 6 months
10.patients who received pars plana vitrectomy or submacular surgery
11.patinets with intra or external occular infection or inflamation
12.patients with uveitis in any eye
13.fluorescein or indocianine green alergy
14.pregnancy or possibility of pregnancy or woman who are lactating
15.patient who are judged unsuitable for the investigation by the doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Yamamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1 Inohana,Chuo-ku,Chiba 2608670,Japan
TEL
043-222-7171
shuyama@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayasu Kitahashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1 Inohana,Chuo-ku,Chiba 2608670,Japan
TEL
043-222-7171
Homepage URL
kitahashi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Science
Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
千葉大学医学部附属病院眼科(千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 14 | Day |
Other
Other related information
prospective observentional study
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018394
