UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008040 |
|---|---|
| Receipt number | R000009469 |
| Scientific Title | A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization |
| Date of disclosure of the study information | 2012/05/29 |
| Last modified on | 2014/12/01 12:26:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Acronym
A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Scientific Title
A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Scientific Title:Acronym
A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of S-646240 when administered subcutaneously at a dose of 2mg to patients with AMD accompanied by CNV.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety: The incidence of adverse event and adverse drug reaction.
Efficacy: Change in best-corrected visual acuity (BCVA) scores in the study eye, using ETDRS chart.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Patients will receive 2 mg (2 mL) of S-646240 subcutaneously in the cervical region or axilla every week from the initiation of study treatment to Week 4 and every two weeks from Week 4 to Week 22.
Interventions/Control_2
Patients will receive 2 mg (2 mL) of S-646240 subcutaneously in the cervical region or axilla every two weeks from the initiation of study treatment to Week 22.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients in whom active lesion of new-onset CNV in central retinal subfovea of the study eye which cause AMD was found by fluorescein angiography and indocyanine green angiography. (The study eye should be one eye or another.)
(2) Patients whose BCVA score in the study eye, using ETDRS chart, is between 20/25 and 20/200 (between 80 and 35 of letter score).
Key exclusion criteria
(1) Patients who have CNV due to other causes than age.
(2) Patients who have previous or present retinal vessel disease other than AMD.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuko Sawada |
Organization
Shionogi & Co., Ltd.
Division name
Global Development
Zip code
Address
12-4, Sagisu 5-chome, Fukushima-ku, Osaka 553-0002, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shionogi & Co., Ltd.
Division name
Corporate Communications Department
Zip code
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
Homepage URL
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 05 | Month | 29 | 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
| 2012 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009469
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
