UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020177 |
|---|---|
| Receipt number | R000023281 |
| Scientific Title | Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization |
| Date of disclosure of the study information | 2015/12/14 |
| Last modified on | 2021/12/26 22:56:40 |
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Basic information
Public title
Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Acronym
Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Scientific Title
Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Scientific Title:Acronym
Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Region
| Japan |
Condition
Condition
myopic choroidal neovascularization
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the long-term visual outcome of myopic choroidal neovascularization (CNV) treated with intravitreal injection of ranibizumab (IVR) in 2-year follow-up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the best collected visual acuity(BCVA) at 2 years after IVR compared to the baseline in patients with myopic CNV.
Key secondary outcomes
1)Absolute BCVA value at 2 years
2)The rate of absence of dye leakage from CNV at 2 years after IVR
3)The number of IVR for 2 years
4)The number of CNV recurrence for 2-year period
5)The CNV size (every 6 months for 2 years)
6)The central retinal thickness (every 6 months for 2 years)
7)The subfoveal choroidal thickness (every 6 months for 2 years)
8)The subfoveal scleral thickness (every 6 months for 2 years)
9)The rate of developing CNV-related chorioretinal atrophy at 2 years after IVR
10)The size of CNV-related chorioretinal atrophy at 2 years after IVR
11)The prognostic factors for the mean change of BCVA at 2 years
12)The prognostic factors for loss of CNV activity (absence of dye leakage) at 2 years
13)The prognostic factors for the size of chorioretinal atrophy at 2 years
14)The patient satisfaction at 2 years compared to the baseline
15)The incidence rate of ocular and systemic adverse events
16)Based on the above data (1-15), we would like to establish the treatment guideline for up to 2 years for myopic CNV.
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) high myopia (axial length > 26.5 mm)
2) active CNV at the treatment (the presence of dye leakage on fluorescein angiogram)
3) a long-term follow-up of > 2 years after ranibizumab injection. The patients who participated in the RADIANCE study are also included in the study.
Key exclusion criteria
1) a history of other treatments for myopic CNV (PDT, other anti-VEGF reagents than ranibizumab)
2) a history of vitreoretinal surgery
3) a presence of other ocular complications which could affect the vision (dense cataract, foveal retinal detachment, macular holes, etc.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ohno-Matsui |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5302
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Onishi |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5302
Homepage URL
yuka0204@gmail.com
Sponsor or person
Institute
Ophthalmology of Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K. (Novartis Pharmaceuticals Japan)
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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
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
東京医科歯科大学医学部附属病院（東京都文京区）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 14 | 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
51
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study to analyze the clinical data of the patients with myopic CNV who had treatment with IVR between December 1 2010 and December 31 2013, and have been followed up at High Myopia Clinic of Tokyo Medical and ental University for at least 2 years.
The patients have been followed regularly (at least every 6 months) for 2 years. Ocular examinations including OCT, fundus photos, fluorescein angiography, and fundus autofluorescence were regularly performed for all the patients.
1)patient demographics(at baseline) : age, gender, medical history
2)ocular demographics(at baseline) : refractive error(D), axial length(mm), presence of posterior staphyloma, types of posterior staphyloma
3)BCVA (at baseline and every 6 month)
4)fluorescein angiography(at baseline and every 6 month): CNV size, dye leakage from CNV
5)optical coherence tomography(OCT)(at baseline and every 6 month) : presence of serous retinal detachment, presence of intraretinal edema, presence of macular retinoschisis, the maximum height of CNV, the central retinal thickness, the subfoveal choroidal thickness, the subfoveal screal thickness
6)fundus autofluorescence(every 6 month) : presence of CNV-related atrophy, the size of CNV-related atrophy
7)vision-related QOL(NEI VFQ-25)(at 2 year)
For controls, we have remarkably large series of historical controls who were followed up without any treatment for more than 5 years (around 100 patients). These patients were regularly followed at least every 6 months. The data of the historical controls are retrospectively analyzed and used to compare the outcome with ranibizumab-treated patients.
Management information
Registered date
| 2015 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023281
