UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014056 |
|---|---|
| Receipt number | R000016367 |
| Scientific Title | Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2019/03/08 18:26:33 |
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Basic information
Public title
Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Acronym
Treat and exted regimen in exdative age related macular degeneration
Scientific Title
Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Scientific Title:Acronym
Treat and exted regimen in exdative age related macular degeneration
Region
| Japan |
Condition
Condition
Age related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the simplified treat and extend regimen using ranibizumab about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of best corrected visual acuity and central retinal thickness (at 12th and 24th months).
Key secondary outcomes
1:A drop-out rate of the third month and the twelfth month
2:The study continuance rate until 24 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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ranibizumab
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
Subjects were eligible if the following criteria were met.
1) ability to provide written informed consent for this study
2) age>=50years old
3) intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical AMD and PCV)
4) best corrected visual acuity>=0.05
Key exclusion criteria
1) past intravitreal anti-VEGF therapy in the study eye
2) past intravitreal or subtenon injection of steroid therapy in the study eye
3) past vitrectomy therapy in the study eye
4) infection or suspicion of infection in eyes or periocular region
5) severe intraocular inflammation in eyes
6) past allergic reaction for ranibizumab
7) past allergic reaction for fluorescein, indocyanine green or iodine
8) pregnancy (positive pregnancy test) or lactating women
9) other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174 Edobashi Tsu, Mie, Japan
TEL
059-232-1111
ganka@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Matsubara |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174 Edobashi Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
hmastu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K
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
| 2014 | Year | 06 | 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
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 05 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016367
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/03/08 | 研究実施計画書簡易 .doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/03/08 | データー仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/03/08 | UMIN登録最終.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/16367
