UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027799 |
|---|---|
| Receipt number | R000031853 |
| Scientific Title | Prospective study of Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration in Japanese Patients |
| Date of disclosure of the study information | 2017/06/18 |
| Last modified on | 2017/06/19 17:29:03 |
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Basic information
Public title
Prospective study of Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration in Japanese Patients
Acronym
Ranibizumab for Exudative Age-Related Macular Degeneration
Scientific Title
Prospective study of Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration in Japanese Patients
Scientific Title:Acronym
Ranibizumab for Exudative Age-Related Macular Degeneration
Region
| Japan |
Condition
Condition
Exudative Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ranibizumab for exudative age-related macular degeneration in Japanese with prospective treatment regimen
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
The mean changes of best-corrected visual acuity at month 24 compared with baseline
Key secondary outcomes
The prevalence of eyes with only ranibizumab by PRN (pro re nata)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ranibizumab ; Monthly (3 times) to PRN regimen
Interventions/Control_2
Ranibizumab ; Monthly (3 times) to Treat and Extend regimen
Interventions/Control_3
Ranibizumab ; Monthly (3 times) to Treat and Extend regimen
followed by
Aflibercept ; Treat and Extend regimen
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) naive neovascular AMD with older than 50 years and acceptance of this study
2) typical AMD
Key exclusion criteria
1) previous treatment for AMD
2) polypoidal choroidal vasculopathy
3) retinal angiomatous proliferation
4) diabetic maculopathy, retinal vascular occlusion, or idiopathic macular telangiectasia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Saito |
Organization
Akita University
Division name
Department of Ophthalmology
Zip code
Address
44-2 Hasunuma-Hiroomote, Akita city, Akita, Japan
TEL
018-834-1111
masaaki@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Saito |
Organization
Akita University
Division name
Department of Ophthalmology
Zip code
Address
44-2 Hasunuma-Hiroomote, Akita city, Akita, Japan
TEL
018-834-1111
Homepage URL
masaaki@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Alcon Pharmaceuticals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akita City Hospital
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
秋田大学病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
| 2017 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031853
